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Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

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ClinicalTrials.gov Identifier: NCT02216812
Recruitment Status : Completed
First Posted : August 15, 2014
Results First Posted : September 17, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Neal Chung-Jen Chen, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Finger Stiffness
Distal Radius Fracture
Interventions Drug: 500 mg vitamin c, 1 pill per day for 6 weeks
Drug: 1 placebo pill for 6 weeks
Enrollment 134
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 500 mg Vitamin C Placebo
Hide Arm/Group Description

Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks

500 mg vitamin c, 1 pill per day for 6 weeks

Arm will take 1 placebo pill per day for 6 weeks

1 placebo pill for 6 weeks

Period Title: Overall Study
Started 67 67
Completed 57 62
Not Completed 10 5
Reason Not Completed
Lost to Follow-up             10             5
Arm/Group Title 500 mg Vitamin C Placebo Total
Hide Arm/Group Description

Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks

500 mg vitamin c, 1 pill per day for 6 weeks

Arm will take 1 placebo pill per day for 6 weeks

1 placebo pill for 6 weeks

Total of all reporting groups
Overall Number of Baseline Participants 67 67 134
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 67 participants 134 participants
48  (17) 50  (17) 49  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 67 participants 134 participants
Female
47
  70.1%
52
  77.6%
99
  73.9%
Male
20
  29.9%
15
  22.4%
35
  26.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Non-causcasian Number Analyzed 67 participants 67 participants 134 participants
13
  19.4%
4
   6.0%
17
  12.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 67 participants 67 participants 134 participants
67
 100.0%
67
 100.0%
134
 100.0%
Dominant extremity injured   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 67 participants 134 participants
32
  47.8%
32
  47.8%
64
  47.8%
[1]
Measure Description: The number of participants whose injured arm is the same side as that of their dominant hand (i.e., the hand with which they write or perform fine motor skills).
Non-operative treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 67 participants 134 participants
42
  62.7%
41
  61.2%
83
  61.9%
Carpal tunnel release  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 67 participants 134 participants
4
   6.0%
9
  13.4%
13
   9.7%
PROMIS Pain Interference CAT   [1] 
Mean (Standard Deviation)
Unit of measure:  T-score
Number Analyzed 67 participants 67 participants 134 participants
65  (6.4) 61  (7.1) 63  (7.0)
[1]
Measure Description: The Patient Reported Outcome Information System (PROMIS) Pain Interference Computer Adaptive Test (CAT) is a computerized assessment measuring the amount pain interferes in the subjects' activities. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T scores above 50 represents more of the measured variable than the average. Investigators measured this at enrollment.
1.Primary Outcome
Title Distance to Palmar Crease Index Through Small Finger
Hide Description To establish the distance to palmar crease, we asked patients to make a fist and determine the distance from nail tip to palmar crease for each individual digit using a ruler. We defined total distance to palmar crease as the sum of the values for the index, long, ring, and small fingers.
Time Frame Day 1 (baseline), 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.
Arm/Group Title 500 mg Vitamin C Placebo
Hide Arm/Group Description:

Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks

500 mg vitamin c, 1 pill per day for 6 weeks

Arm will take 1 placebo pill per day for 6 weeks

1 placebo pill for 6 weeks

Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: Centimeters
Day 1 (baseline) Number Analyzed 67 participants 67 participants
6.7  (6.7) 7.1  (6.0)
6 weeks Number Analyzed 57 participants 62 participants
2.3  (4.0) 2.0  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 500 mg Vitamin C, Placebo
Comments We tested the null hypothesis that there is no difference in DPC six weeks after fracture of the distal radius between patients taking vitamin C and placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
2.Secondary Outcome
Title Active Flexion Index Through Small Finger
Hide Description Active flexion will be measured using a handheld goniometer. We calculate total active flexion of the index through small finger by summing flexion at the metacarpo-phalangeal, proximal interphalangeal and distal interphalangeal joints
Time Frame Day 1 (baseline), 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.
Arm/Group Title 500 mg Vitamin C Placebo
Hide Arm/Group Description:

Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks

500 mg vitamin c, 1 pill per day for 6 weeks

Arm will take 1 placebo pill per day for 6 weeks

1 placebo pill for 6 weeks

Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: Degrees
Day 1 (baseline) Number Analyzed 67 participants 67 participants
725  (159) 732  (144)
6 weeks Number Analyzed 57 participants 62 participants
896  (108) 904  (132)
3.Secondary Outcome
Title Thumb Motion
Hide Description Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar andabduction
Time Frame Day 1 (baseline), 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.
Arm/Group Title 500 mg Vitamin C Placebo
Hide Arm/Group Description:

Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks

500 mg vitamin c, 1 pill per day for 6 weeks

Arm will take 1 placebo pill per day for 6 weeks

1 placebo pill for 6 weeks

Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: Degrees
Day 1 (baseline) Number Analyzed 67 participants 67 participants
161  (59) 155  (49)
6 weeks Number Analyzed 57 participants 62 participants
229  (49) 232  (46)
4.Secondary Outcome
Title PROMIS Upper Extremity - CAT
Hide Description The Patient Reported Outcome Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) is a computerized assessment measuring the physical function of the upper extremity. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T-score above 50 represents more of the measured variable than the average. For this variable, a T-score above 50 indicates greater physical function than the average population.
Time Frame Day 1 (baseline), 6 weeks, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.
Arm/Group Title 500 mg Vitamin C Placebo
Hide Arm/Group Description:

Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks

500 mg vitamin c, 1 pill per day for 6 weeks

Arm will take 1 placebo pill per day for 6 weeks

1 placebo pill for 6 weeks

Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: T-score
Day 1 (Baseline) Number Analyzed 67 participants 67 participants
26  (7.9) 27  (7.5)
6 weeks Number Analyzed 57 participants 62 participants
35  (6.9) 36  (8.4)
6 months Number Analyzed 48 participants 50 participants
48  (8.4) 48  (9.1)
5.Secondary Outcome
Title 0-10 Ordinal Pain Score
Hide Description Measure Description: The Ordinal Pain Scale measures the amount of pain on a scale from 0, no pain, to 10, worst possible pain. The investigators will compare the change in pain between the two cohorts after 6 weeks of treatment and 6 months after treatment.
Time Frame Day 1 (baseline), 6 weeks, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects were lost to follow up between time of enrollment and 6 week and 6 month follow up
Arm/Group Title 500 mg Vitamin C Placebo
Hide Arm/Group Description:

Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks

500 mg vitamin c, 1 pill per day for 6 weeks

Arm will take 1 placebo pill per day for 6 weeks

1 placebo pill for 6 weeks

Overall Number of Participants Analyzed 67 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 1 (baseline) Number Analyzed 67 participants 67 participants
3.5  (2.4) 3.8  (2.6)
6 weeks Number Analyzed 57 participants 67 participants
1.6  (2.2) 1.8  (1.9)
6 months Number Analyzed 48 participants 50 participants
1.4  (2.3) 1.7  (2.2)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 500 mg Vitamin C Placebo
Hide Arm/Group Description

Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks

500 mg vitamin c, 1 pill per day for 6 weeks

Arm will take 1 placebo pill per day for 6 weeks

1 placebo pill for 6 weeks

All-Cause Mortality
500 mg Vitamin C Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   0/67 (0.00%) 
Hide Serious Adverse Events
500 mg Vitamin C Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   0/67 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
500 mg Vitamin C Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   0/67 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Neal Chen
Organization: Massachusetts General Hospital
Phone: 617-726-4700
EMail: nchen1@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Neal Chung-Jen Chen, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02216812    
Other Study ID Numbers: 2014P000561
First Submitted: August 12, 2014
First Posted: August 15, 2014
Results First Submitted: June 29, 2018
Results First Posted: September 17, 2018
Last Update Posted: August 14, 2019