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Study To Understand Fall Reduction and Vitamin D in You (STURDY)

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ClinicalTrials.gov Identifier: NCT02166333
Recruitment Status : Terminated
First Posted : June 18, 2014
Results First Posted : May 14, 2021
Last Update Posted : May 14, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Vitamin D Deficiency
Falls
Interventions Dietary Supplement: 200 IU/d cholecalciferol
Dietary Supplement: 1000 IU/d cholecalciferol
Dietary Supplement: 2000 IU/d cholecalciferol
Dietary Supplement: 4000 IU/d cholecalciferol
Enrollment 688
Recruitment Details From October 2015 to March 2018, new participants were randomized in the trial's Stage 1 and began their individual 2-year period of trial participation. Stage 1 ended on March 23, 2018 and Stage 2 began; randomization continued but to the 200 and 1000 groups only. Some participants completed their 2 years of participation during Stage 1, some participants had follow-up time during both Stage 1 and Stage 2, and some participants began their 2 years of participation during Stage 2.
Pre-assignment Details  
Arm/Group Title Randomized to 200 IU/d in Stage 1 Additional Participants Randomized to 200 IU/d in Stage 2 Randomized to 1000 IU/d in Stage 1 Additional Participants Randomized to 1000 IU/d in Stage 2 Randomized to 2000 IU/d in Stage 1 and Switched to 1000 IU/d in Stage 2 Randomized to 4000 IU/d in Stage 1 and Switched to 1000 IU/d in Stage 2
Hide Arm/Group Description These participants received 200 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually throughout their trial participation; those who continued to Stage 2 (neither completed the trial [completed the 2-year visit], nor died, nor dropped out during Stage 1) continued to receive 200 IU/d cholecalciferol during Stage 2. These participants began their study participation in Stage 2 and received 200 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually throughout their participation. These participants received 1000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually throughout their trial participation; those who continued to Stage 2 (neither completed the trial [completed the 2-year visit], nor died, nor dropped out during Stage 1) continued to receive 1000 IU/d cholecalciferol during Stage 2. These participants began their study participation in Stage 2 and received 1000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually throughout their participation. These participants received 2000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually in Stage 1; those who continued to Stage 2 were switched to 1000 IU/d cholecalciferol (vitamin D3) tablets during Stage 2. These participants received 4000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually in Stage 1; those who continued to Stage 2 were switched to 1000 IU/d cholecalciferol (vitamin D3) tablets during Stage 2.
Period Title: Stage 1
Started 262 0 130 0 68 [1] 69 [2]
Completed [3] 242 0 122 0 59 63
Not Completed 20 0 8 0 9 6
Reason Not Completed
Finished the trial (did the 2 year visit) during Stage 1 and did not advance to Stage 2             4             0             0             0             3             1
Death             4             0             2             0             3             2
Lost to Follow-up             12             0             6             0             3             3
[1]
Randomization to 2000 IU/d was stopped in February 2018 as part of planned dose-finding
[2]
Randomization to 4000 IU/d was stopped in March 2018 as part of planned dose-finding
[3]
In Stage 1, completed = started Stage 2
Period Title: Stage 2
Started 242 77 122 82 59 63
Completed [1] 35 71 47 73 2 4
Not Completed 207 6 75 9 57 59
Reason Not Completed
Finished the trial (did the 2 year visit) prior to or during trial closeout             180             0             63             0             54             52
Death             4             2             1             0             0             1
Lost to Follow-up             23             4             11             9             3             6
[1]
In Stage 2, completed = participated in closeout (April-May 2019)
Arm/Group Title 200 IU/d 1000 IU/d 2000 IU/d 4000 IU/d Total
Hide Arm/Group Description The 200 IU/d group is the control group. During dose-finding, the 1000 IU/d dose was identified as the best of the non-control doses for fall prevention. Randomization to the 2000 IU/d group was stopped in February 2018 as part of planned dose-finding. Randomization to the 4000 IU/d group was stopped in March 2018 as part of planned dose-finding. Total of all reporting groups
Overall Number of Baseline Participants 339 212 68 69 688
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 339 participants 212 participants 68 participants 69 participants 688 participants
77.2  (5.4) 76.5  (5.3) 77.3  (4.6) 79.1  (5.9) 77.2  (5.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 212 participants 68 participants 69 participants 688 participants
Female
141
  41.6%
102
  48.1%
29
  42.6%
28
  40.6%
300
  43.6%
Male
198
  58.4%
110
  51.9%
39
  57.4%
41
  59.4%
388
  56.4%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 335 participants 210 participants 67 participants 69 participants 681 participants
276
  82.4%
159
  75.7%
51
  76.1%
57
  82.6%
543
  79.7%
Black Number Analyzed 335 participants 210 participants 67 participants 69 participants 681 participants
55
  16.4%
44
  21.0%
15
  22.4%
10
  14.5%
124
  18.2%
Other Number Analyzed 335 participants 210 participants 67 participants 69 participants 681 participants
7
   2.1%
12
   5.7%
2
   3.0%
2
   2.9%
23
   3.4%
Hispanic, Latino or Spanish ethnicity Number Analyzed 336 participants 211 participants 68 participants 69 participants 684 participants
3
   0.9%
3
   1.4%
1
   1.5%
1
   1.4%
8
   1.2%
[1]
Measure Analysis Population Description: 7 participants were missing race information, 4 participants were missing ethnicity information
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 339 participants 212 participants 68 participants 69 participants 688 participants
339
 100.0%
212
 100.0%
68
 100.0%
69
 100.0%
688
 100.0%
Serum vitamin D (nmol/L)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 212 participants 68 participants 69 participants 688 participants
25 to 49 nmol/L
100
  29.5%
53
  25.0%
25
  36.8%
22
  31.9%
200
  29.1%
50 to 72.5 nmol/L
239
  70.5%
159
  75.0%
43
  63.2%
47
  68.1%
488
  70.9%
[1]
Measure Description: The range of serum vitamin D levels eligible for the trial (25-72.5 nmol/L) includes those termed deficient (<50 nmol/L) or insufficient (50-72.5 nmol/L) by the Endocrine Society and overlaps with those termed deficient (<30 nmol/L), inadequate (30 to <50 nmol/L), or adequate (≥50 nmol/L) by the Institute of Medicine.
Taking a vitamin D supplement  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 212 participants 68 participants 69 participants 688 participants
124
  36.6%
82
  38.7%
27
  39.7%
23
  33.3%
256
  37.2%
Total vitamin D intake (IU/day)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 212 participants 68 participants 69 participants 688 participants
< 200
125
  36.9%
77
  36.3%
21
  30.9%
30
  43.5%
253
  36.8%
200-399
68
  20.1%
40
  18.9%
16
  23.5%
14
  20.3%
138
  20.1%
400-799
63
  18.6%
39
  18.4%
10
  14.7%
13
  18.8%
125
  18.2%
>= 800
83
  24.5%
56
  26.4%
21
  30.9%
12
  17.4%
172
  25.0%
Fell at least once in prior year  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 212 participants 68 participants 69 participants 688 participants
221
  65.2%
139
  65.6%
43
  63.2%
47
  68.1%
450
  65.4%
Fell and hurt self in prior year  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 212 participants 68 participants 69 participants 688 participants
130
  38.3%
81
  38.2%
21
  30.9%
30
  43.5%
262
  38.1%
Fell at least twice in prior year  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 212 participants 68 participants 69 participants 688 participants
120
  35.4%
83
  39.2%
26
  38.2%
30
  43.5%
259
  37.6%
Afraid of falling due to balance or walking problem   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 211 participants 68 participants 69 participants 687 participants
290
  85.5%
190
  90.0%
65
  95.6%
56
  81.2%
601
  87.5%
[1]
Measure Analysis Population Description: 1 participant in the 1000 IU/day group did not answer the question regarding fear of falling due to balance or walking problem.
Difficulty maintaining balance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 212 participants 68 participants 69 participants 688 participants
173
  51.0%
99
  46.7%
33
  48.5%
38
  55.1%
343
  49.9%
Uses cane, walker or other assistive device to walk   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 211 participants 68 participants 69 participants 687 participants
91
  26.8%
64
  30.3%
24
  35.3%
25
  36.2%
204
  29.7%
[1]
Measure Analysis Population Description: 1 participant in the 1000 IU/day group did not answer the question about using an assistive device to walk.
Short Physical Performance Battery score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 212 participants 68 participants 69 participants 688 participants
0 to 3
12
   3.5%
12
   5.7%
3
   4.4%
3
   4.3%
30
   4.4%
4 to 6
34
  10.0%
18
   8.5%
12
  17.6%
11
  15.9%
75
  10.9%
7 to 9
131
  38.6%
92
  43.4%
30
  44.1%
24
  34.8%
277
  40.3%
10 to 12
162
  47.8%
90
  42.5%
23
  33.8%
31
  44.9%
306
  44.5%
[1]
Measure Description: The Short Physical Performance Battery (SPPB) is a 3-part assessment of physical functioning: balance testing, gait speed testing (timed 4-meter walk at usual pace), and demonstration of ability to complete 5 chair stands; each part is scored 0 to 4 and the 3 subscores are summed to obtain the total score which ranges from 0 to 12. Higher scores indicate better physical function.
Gait speed (m/sec)   [1] 
Mean (Standard Deviation)
Unit of measure:  Meters per second
Number Analyzed 338 participants 210 participants 68 participants 69 participants 685 participants
0.89  (0.23) 0.85  (0.23) 0.80  (0.23) 0.85  (0.23) 0.86  (0.24)
[1]
Measure Analysis Population Description: 1 participant in the 200 IU/day group and 2 participants in the 1000 IU/day group were missing gait speed at baseline
Frailty status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 339 participants 211 participants 68 participants 69 participants 687 participants
Robust
104
  30.7%
51
  24.2%
25
  36.8%
18
  26.1%
198
  28.8%
Pre-frail
205
  60.5%
127
  60.2%
36
  52.9%
40
  58.0%
408
  59.4%
Frail
30
   8.8%
33
  15.6%
7
  10.3%
11
  15.9%
81
  11.8%
[1]
Measure Analysis Population Description: One participant in the 1000 IU/day group was missing frailty status at baseline.
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 339 participants 211 participants 68 participants 69 participants 687 participants
30.4  (6.3) 30.7  (5.2) 30.7  (6.4) 30.3  (6.2) 30.5  (6.0)
[1]
Measure Analysis Population Description: 1 participant in the 1000 IU/day group was missing BMI at baseline.
SF-12 physical health component score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 335 participants 211 participants 68 participants 69 participants 683 participants
44.5  (10.3) 42.9  (11.0) 42.9  (10.2) 44.0  (9.9) 43.8  (10.5)
[1]
Measure Description: The Short-Form 12-Item Health Survey (4-week recall) v2 (SF-12) is an interviewer-administered 12-item scale measuring a person's perceptions of their health and health-related quality of life; the physical component score is based on responses to 6 items and has a normative mean (SD) of 50 (10) (range 0 to 100). Higher scores indicate better physical health.
[2]
Measure Analysis Population Description: 4 participants in the 200 IU/day group and 1 participant in the 1000 IU/day group were missing the SF-12 physical component score at baseline.
SF-12 mental health component score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 335 participants 211 participants 68 participants 69 participants 683 participants
55.1  (7.7) 55.4  (7.6) 54.5  (8.4) 54.3  (9.4) 55.0  (7.9)
[1]
Measure Description: The Short-Form 12-Item Health Survey (4-week recall) v2 (SF-12) is an interviewer-administered 12-item scale measuring a person's perceptions of their health and health-related quality of life; the mental component score is based on responses to 6 items and has a normative mean (SD) of 50 (10) (range 0 to 100). Higher scores indicate better mental health.
[2]
Measure Analysis Population Description: 4 participants in the 200 IU/day group and 1 participant in the 1000 IU/day group were missing the SF-12 mental component score at baseline.
1.Primary Outcome
Title Incidence of First Fall or Death (Whichever Comes First)
Hide Description Falls were ascertained by a monthly fall calendar completed by each participant, scheduled interviews at 1 month and 3 months after randomization and every 3 months thereafter up to 24 months or trial end. Death was ascertained primarily by reports from family or friends.
Time Frame Randomization to 24 months or end of trial, whichever came first
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis compares the Experience on Best Dose group versus the 200 IU/d group. The Experience on Best Dose group includes all participants assigned or switched to best dose, with their data limited to data while on best dose. This group excludes 41 participants randomized to 2000 or 4000 IU/d who were never issued a bottle of 1000 IU/d because they completed the trial, died, dropped out, or stopped using study pills without ever being switched to 1000 IU/d.
Arm/Group Title Experience on Best Dose 200 IU/d Pooled Higher Doses
Hide Arm/Group Description:
The Experience on Best Dose group includes 121 participants randomized to 1000 IU/d during dose-finding and 96 participants randomized to 2000 or 4000 IU/d during dose-finding who were issued at least one bottle of 1000 IU after dose-finding ended, plus 91 participants randomized to 1000 IU/d after dose-finding ended, for a total of 308 participants who had experience on the dose selected as best of the non-control doses for preventing falls. This group excludes 41 participants randomized to 2000 or 4000 IU/d who were never issued a bottle of 1000 IU/d because they completed the trial, died, dropped out, or stopped using study pills without ever being switched to 1000 IU/d.
The 200 IU/d group is the control group and includes participants randomized to 200 IU/d during Stage 1 and participants randomized to 200 IU/d during Stage 2.
All participants randomized to 1000, 2000, or 4000 IU/d during Stage 1 and all participants randomized to 1000 IU/d during Stage 2.
Overall Number of Participants Analyzed 308 339 349
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: First fall or death per 100 person-years
76.9
(65.8 to 89.9)
76.0
(66.5 to 86.9)
78.0
(68.3 to 89.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experience on Best Dose, 200 IU/d
Comments The Experience on Best Dose group includes all participants assigned or switched to best dose (1000 IU/day) and excludes 41 participants randomized to 2000 or 4000 IU/day who were never issued a bottle of best dose. For those randomized to 2000 or 4000 IU/day, at-risk time and events are measured from the date of their switch to best dose. 150 Experience on Best Dose participants (median follow-up, 10.2 mos) and 125 200 IU/day participants (median follow-up, 20.3 mos) were censored.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments The P value is nominal and two-sided.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.76 to 1.15
Estimation Comments The Experience on Best Dose versus 200 IU/day hazard ratio and its 95% confidence interval were derived from a Cox regression model with dose group as the single model variable.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 200 IU/d, Pooled Higher Doses
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.86 to 1.25
Estimation Comments The comparison of the Pooled Higher Doses group versus the 200 IU/d group is a sensitivity analysis.
2.Secondary Outcome
Title Change in Gait Speed
Hide Description Gait speed in meters per second (m/s) was obtained from the timed 4-meter, usual-paced walk component of the Short Physical Performance Battery. The change in gait speed was obtained as follow-up measure minus baseline measure.
Time Frame Baseline, 3 months, 12 months and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Change in gait speed since randomization was evaluated in the Pooled Higher Doses group versus the 200 IU/d group.
Arm/Group Title Pooled Higher Doses 200 IU/Day
Hide Arm/Group Description:
The Pooled Higher Doses group includes all participants randomized to 1000, 2000, or 4000 IU/d (n=349).
The 200 IU/d group is the control group.
Overall Number of Participants Analyzed 349 339
Mean (Standard Deviation)
Unit of Measure: m/s
Change at 3 months -0.01  (0.17) -0.01  (0.18)
Change at 12 months -0.04  (0.17) -0.04  (0.20)
Change at 24 months -0.03  (0.16) -0.09  (0.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pooled Higher Doses, 200 IU/Day
Comments The two groups were assessed for differential change over time in change from baseline using a longitudinal mixed effects regression model with gait speed as the outcome and fixed effects including a single treatment term, 3 time point terms and 3 treatment-by-time interaction terms and a random intercept for participant.
Type of Statistical Test Superiority
Comments The overall P tests for difference between groups in differential change from baseline over time and is from a 3 degree of freedom test of the combined 3 treatment-by-time interaction terms from the longitudinal mixed effects model.
Statistical Test of Hypothesis P-Value 0.15
Comments The P value is nominal and not adjusted for multiple comparisons.
Method Regression, Linear
Comments 3 degree of freedom interaction test
Time Frame Adverse event information was collected from randomization to last date of participation in the trial, up to 24 months.
Adverse Event Reporting Description Adverse events are reported for the Pooled Higher Doses group (those randomized to 1000, 2000, or 4000 IU) vs. the control group (those randomized to 200 IU) to be consistent with how the study outcomes are reported, because the Pooled Higher Doses and control groups have comparable numbers and follow-up, and because the 2000 and 4000 IU groups received 1000 IU after 1000 IU was selected as best non control dose. Also shown are counts of adverse event by dose in use when the event occurred.
 
Arm/Group Title Pooled Higher Doses 200 IU/d Those With Experience on 1000 IU Those With Experience on 2000 IU Those With Experience on 4000 IU
Hide Arm/Group Description The Pooled Higher Doses group includes all participants randomized to 1000, 2000, or 4000 IU/d. The 200 IU/d group is the control group. This group includes those randomized to 1000 IU and 96 participants randomized to 2000 or 4000 who were issued at least 1 bottle of 1000 IU. Note that participants who switched doses during the trial may have an event while in their original group as well as in the 1000 group if the event recurred after switching to 1000 IU. Only those randomized to 2000 IU are in this group. Only those randomized to 4000 IU are in this group.
All-Cause Mortality
Pooled Higher Doses 200 IU/d Those With Experience on 1000 IU Those With Experience on 2000 IU Those With Experience on 4000 IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/349 (2.58%)   10/339 (2.95%)   4/308 (1.30%)   3/68 (4.41%)   2/69 (2.90%) 
Hide Serious Adverse Events
Pooled Higher Doses 200 IU/d Those With Experience on 1000 IU Those With Experience on 2000 IU Those With Experience on 4000 IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   82/349 (23.50%)   68/339 (20.06%)   49/308 (15.91%)   17/68 (25.00%)   17/69 (24.64%) 
Cardiac disorders           
Atrial fibrillation * 1  1/349 (0.29%)  4/339 (1.18%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Atrial flutter * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Cardiac arrest * 1  2/349 (0.57%)  0/339 (0.00%)  0/308 (0.00%)  2/68 (2.94%)  0/69 (0.00%) 
Cardiac disorder * 1  1/349 (0.29%)  1/339 (0.29%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Cardiac failure * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Cardiac failure congestive * 1  3/349 (0.86%)  3/339 (0.88%)  1/308 (0.32%)  1/68 (1.47%)  1/69 (1.45%) 
Myocardial infarction * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Tachycardia * 1  2/349 (0.57%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  1/69 (1.45%) 
Arrhythmia * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Coronary artery occlusion * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Ventricular extrasystoles * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Gastrointestinal disorders           
Abdominal pain upper * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Colitis * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Diarrhea * 1  1/349 (0.29%)  2/339 (0.59%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Gastrointestinal hemorrhage * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Gastrointestinal polyp hemorrhage * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Rectal hemorrhage * 1  3/349 (0.86%)  1/339 (0.29%)  3/308 (0.97%)  0/68 (0.00%)  0/69 (0.00%) 
Vomiting * 1  2/349 (0.57%)  1/339 (0.29%)  0/308 (0.00%)  2/68 (2.94%)  0/69 (0.00%) 
Constipation * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Abdominal pain * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Fecaloma * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Gastric ulcer * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Hiatus hernia * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Nausea  1  2/349 (0.57%)  1/339 (0.29%)  0/308 (0.00%)  2/68 (2.94%)  0/69 (0.00%) 
Volvulus * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
General disorders           
Abasia * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Asthenia * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Chest pain * 1  2/349 (0.57%)  2/339 (0.59%)  2/308 (0.65%)  0/68 (0.00%)  0/69 (0.00%) 
Chills * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Fatigue * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Gait disturbance * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Medical device complication * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Peripheral swelling * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Polyp * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Pyrexia * 1  2/349 (0.57%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  1/69 (1.45%) 
Unevaluable event * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Device malfunction * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Necrosis * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Ulcer * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Hepatobiliary disorders           
Bile duct stone * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Cholecystitis * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Hepatic cirrhosis * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Hepatic failure * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Cholelithiasis * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Immune system disorders           
Hypersensitivity * 1  2/349 (0.57%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  1/69 (1.45%) 
Infections and infestations           
Bronchitis * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Cellulitis * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Influenza * 1  2/349 (0.57%)  3/339 (0.88%)  1/308 (0.32%)  1/68 (1.47%)  0/69 (0.00%) 
Localized infection * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Pneumonia * 1  7/349 (2.01%)  6/339 (1.77%)  2/308 (0.65%)  4/68 (5.88%)  1/69 (1.45%) 
Sepsis * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Urinary tract infection * 1  3/349 (0.86%)  2/339 (0.59%)  1/308 (0.32%)  1/68 (1.47%)  1/69 (1.45%) 
Viral infection * 1  0/349 (0.00%)  2/339 (0.59%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Bacterial infection * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Kidney infection * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Injury, poisoning and procedural complications           
Contusion  1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Eye injury * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Fall  1  5/349 (1.43%)  1/339 (0.29%)  4/308 (1.30%)  1/68 (1.47%)  0/69 (0.00%) 
Injury * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Post procedural complication * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Skull fracture * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Procedural pain * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Rib fracture * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Road traffic accident * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Investigations           
Blood calcium decreased * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Blood calcium increased * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Blood creatinine increased * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Full blood count decreased * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Blood potassium decreased * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Heart rate decreased * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Heart rate increased * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Heart rate irregular * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Metabolism and nutrition disorders           
Dehydration * 1  2/349 (0.57%)  2/339 (0.59%)  1/308 (0.32%)  1/68 (1.47%)  0/69 (0.00%) 
Diabetes mellitus * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Hypercalcemia * 1  2/349 (0.57%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  1/69 (1.45%) 
Hypocalcemia * 1  3/349 (0.86%)  4/339 (1.18%)  3/308 (0.97%)  0/68 (0.00%)  0/69 (0.00%) 
Hypoglycemia * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Fluid retention * 1  0/349 (0.00%)  2/339 (0.59%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Hyperkalemia * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Back disorder * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Back pain * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Flank pain * 1  0/349 (0.00%)  2/339 (0.59%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Muscle spasms * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Muscular weakness * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Musculoskeletal pain * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Spinal column stenosis * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Arthritis * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Pain in extremity * 1  0/349 (0.00%)  2/339 (0.59%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Brain neoplasm malignant * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Colon cancer * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Lung cancer metastatis * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Neoplasm malignant * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Pancreatic carcinoma * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Prostate cancer * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Squamous carcinoma of skin * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
b-cell lymphoma * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Leukemia * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Myelodysplastic syndrome * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Nervous system disorders           
Carpal tunnel syndrome * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Cerebrovascular accident * 1  3/349 (0.86%)  3/339 (0.88%)  2/308 (0.65%)  0/68 (0.00%)  1/69 (1.45%) 
Cervical radiculopathy * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Dementia * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Dizziness * 1  1/349 (0.29%)  2/339 (0.59%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Hemorrhagic stroke * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Presyncope * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Syncope * 1  2/349 (0.57%)  0/339 (0.00%)  2/308 (0.65%)  0/68 (0.00%)  0/69 (0.00%) 
Cerebral hemorrhage * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Loss of consciousness * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Seizure * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Tremor * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Psychiatric disorders           
Depression * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Anxiety * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Renal and urinary disorders           
Calculus urinary * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Chronic kidney disease * 1  1/349 (0.29%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Nephrolithiasis * 1  1/349 (0.29%)  2/339 (0.59%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Nephropathy * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Renal failure * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Reproductive system and breast disorders           
Prostatic calcification * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Acute pulmonary edema * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Asthma * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Cough * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Dypsnea * 1  4/349 (1.15%)  4/339 (1.18%)  2/308 (0.65%)  1/68 (1.47%)  1/69 (1.45%) 
Hypoxia * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Pneumothorax * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Pulmonary edema * 1  2/349 (0.57%)  1/339 (0.29%)  2/308 (0.65%)  0/68 (0.00%)  0/69 (0.00%) 
Respiratory distress * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Chronic obstructive pulmonary disease * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Pleural effusion * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Pulmonary embolus * 1  1/349 (0.29%)  1/339 (0.29%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Pulmonary fibrosis * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermal cyst * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Hyperhidrosis * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  0/68 (0.00%)  1/69 (1.45%) 
Surgical and medical procedures           
Cardiac pacemaker insertion * 1  1/349 (0.29%)  2/339 (0.59%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Surgery * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Tooth extraction * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
Vascular disorders           
Deep vein thrombosis * 1  2/349 (0.57%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  2/69 (2.90%) 
Hypertension * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Hypertensive crisis * 1  1/349 (0.29%)  0/339 (0.00%)  0/308 (0.00%)  1/68 (1.47%)  0/69 (0.00%) 
Hypotension * 1  1/349 (0.29%)  2/339 (0.59%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Internal hemorrhage * 1  1/349 (0.29%)  1/339 (0.29%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Thrombosis * 1  3/349 (0.86%)  0/339 (0.00%)  3/308 (0.97%)  0/68 (0.00%)  0/69 (0.00%) 
Extremity necrosis * 1  1/349 (0.29%)  0/339 (0.00%)  1/308 (0.32%)  0/68 (0.00%)  0/69 (0.00%) 
Orthostatic hypotension * 1  0/349 (0.00%)  1/339 (0.29%)  0/308 (0.00%)  0/68 (0.00%)  0/69 (0.00%) 
1
Term from vocabulary, MedDRA (18.1)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pooled Higher Doses 200 IU/d Those With Experience on 1000 IU Those With Experience on 2000 IU Those With Experience on 4000 IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   311/349 (89.11%)   299/339 (88.20%)   250/308 (81.17%)   60/68 (88.24%)   63/69 (91.30%) 
Gastrointestinal disorders           
Diarrhea * 1  26/349 (7.45%)  19/339 (5.60%)  16/308 (5.19%)  4/68 (5.88%)  6/69 (8.70%) 
Nausea  1  65/349 (18.62%)  57/339 (16.81%)  44/308 (14.29%)  9/68 (13.24%)  13/69 (18.84%) 
Vomiting  1  38/349 (10.89%)  31/339 (9.14%)  25/308 (8.12%)  7/68 (10.29%)  7/69 (10.14%) 
Infections and infestations           
Influenza * 1  14/349 (4.01%)  17/339 (5.01%)  9/308 (2.92%)  2/68 (2.94%)  3/69 (4.35%) 
Injury, poisoning and procedural complications           
Contusion  1  112/349 (32.09%)  92/339 (27.14%)  71/308 (23.05%)  23/68 (33.82%)  24/69 (34.78%) 
Fall  1  212/349 (60.74%)  207/339 (61.06%)  153/308 (49.68%)  44/68 (64.71%)  47/69 (68.12%) 
Ligament sprain  1  20/349 (5.73%)  15/339 (4.42%)  14/308 (4.55%)  2/68 (2.94%)  4/69 (5.80%) 
Muscle strain  1  58/349 (16.62%)  49/339 (14.45%)  37/308 (12.01%)  5/68 (7.35%)  18/69 (26.09%) 
Skin abrasion  1  95/349 (27.22%)  85/339 (25.07%)  54/308 (17.53%)  22/68 (32.35%)  23/69 (33.33%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  23/349 (6.59%)  34/339 (10.03%)  20/308 (6.49%)  3/68 (4.41%)  0/69 (0.00%) 
Arthritis * 1  26/349 (7.45%)  22/339 (6.49%)  18/308 (5.84%)  4/68 (5.88%)  4/69 (5.80%) 
Back pain * 1  22/349 (6.30%)  14/339 (4.13%)  14/308 (4.55%)  4/68 (5.88%)  4/69 (5.80%) 
Nervous system disorders           
Dizziness * 1  26/349 (7.45%)  25/339 (7.37%)  18/308 (5.84%)  3/68 (4.41%)  6/69 (8.70%) 
1
Term from vocabulary, MedDRA (18.1)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lawrence Appel
Organization: Johns Hopkins University
Phone: 410-955-4156
EMail: lappel@jhmi.edu
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02166333    
Other Study ID Numbers: IRB00063914
U01AG047837 ( U.S. NIH Grant/Contract )
First Submitted: June 16, 2014
First Posted: June 18, 2014
Results First Submitted: February 4, 2021
Results First Posted: May 14, 2021
Last Update Posted: May 14, 2021