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Trial record 1 of 21 for:    " December 28, 2011":" January 27, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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Vitamin D Supplementation in HIV Youth

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ClinicalTrials.gov Identifier: NCT01523496
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : February 6, 2018
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Grace McComsey, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Vitamin D control dose
Drug: Vitamin D supplementation-
Enrollment 190
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV+ With Vit D Supplementation HIV+ Young Adults With Vitamin D Control Dose HIV - With Vitamin D Supplementation HIV - With Vitamin D Control Dose
Hide Arm/Group Description HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose HIV+ receiving Vitamin D low dose: 18,000 IU per month HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month. HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month
Period Title: Overall Study
Started 66 [1] 36 58 [1] 30
Completed 56 32 46 27
Not Completed 10 4 12 3
[1]
The supplementation group includes medium and high dose vitamin D supplementation
Arm/Group Title HIV+ With Vit D Supplementation HIV+ Young Adults With Vitamin D Control Dose HIV - With Vitamin D Supplementation HIV - With Vitamin D Control Dose Total
Hide Arm/Group Description HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose HIV+ receiving Vitamin D low dose: 18,000 IU per month HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month. HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month Total of all reporting groups
Overall Number of Baseline Participants 66 36 58 30 190
Hide Baseline Analysis Population Description
A total of 190 subjects were enrolled, including 102 HIV-infected subjects: 66 on vitamin D supplementation dose, 36 on vitamin D control dose and 88 healthy controls: 58 on vitamin D supplementation dose, 30 on vitamin D control dose. By design, groups were well matched for age, sex and race.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 66 participants 36 participants 58 participants 30 participants 190 participants
20.9
(17.0 to 23.6)
19.9
(15.9 to 21.6)
19.6
(14.4 to 23.2)
18.4
(14.4 to 22.2)
19.9
(15.5 to 23.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 36 participants 58 participants 30 participants 190 participants
Female
22
  33.3%
15
  41.7%
20
  34.5%
15
  50.0%
72
  37.9%
Male
44
  66.7%
21
  58.3%
38
  65.5%
15
  50.0%
118
  62.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 36 participants 58 participants 30 participants 190 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
57
  86.4%
34
  94.4%
47
  81.0%
29
  96.7%
167
  87.9%
White
9
  13.6%
2
   5.6%
11
  19.0%
1
   3.3%
23
  12.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 66 participants 36 participants 58 participants 30 participants 190 participants
66 36 58 30 190
1.Primary Outcome
Title Changes in Serum 25(OH)D3 Levels
Hide Description Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
HIV-infected on vitamin D control or supplementation dose and matched HIV-uninfected group on control or supplementation dose
Arm/Group Title HIV Positive on Vit D Control Dose HIV Positive on Vit D Supplementation Dose HIV Negative on Vitamin D Control Dose HIV Negative on Vitamin D Supplementation Dose
Hide Arm/Group Description:
HIV+ receiving low vitamin D dose 18,000 IU per month
HIV-infected young adults receiving a supplementation dose of vitamin D (either medium dose of 60,000 IU per month or a high dose of 120,000 IU/month)
HIV negative controls receiving Vitamin D low dose: 18,000 IU per month
HIV negative controls receiving Vitamin D medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month
Overall Number of Participants Analyzed 32 56 27 46
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
11
(6 to 20)
22
(14 to 32)
7.5
(4 to 13)
25
(15 to 35)
2.Secondary Outcome
Title Changes in Vitamin D Binding Protein (VDBP)
Hide Description Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
HIV-infected children and young adults and matched healthy control group. Results were not analyzed were captured comparing HIV+ young adults on control or supplementation vit D to HIV - controls
Arm/Group Title HIV + on Vitamin D Control Dose HIV + on Vit D Supplementation Dose HIV Negative on Vit D Control Dose HIV Negative on Vit D Supplementation Dose
Hide Arm/Group Description:
HIV+ receiving vitamin D low dose: 18,000 IU per month
HIV+ receiving Vitamin D supplementation (medium dose: 60,000 IU per month or higher dose: 120,000 IU/month)
HIV negative controls on Vitamin D low dose: 18,000 IU per month
HIV negative controls on vitamin D supplementation: medium dose of 60,000 IU per month or higher dose of 120,000 IU/month
Overall Number of Participants Analyzed 32 56 27 46
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
3.9
(-17.9 to 12)
-8.9
(-41.3 to 13.3)
-11.3
(-202 to 5.4)
-11.7
(-183.6 to -2.5)
Time Frame Adverse events were collected throughout the study duration, at baseline, 6 months, and 12 months.
Adverse Event Reporting Description The same definitions are used. Systematic assessments of adverse events were done at each visit date by questionnaires, physical exam and vitamin D levels assessment by the study team. In case of adverse events they were reported to the principal investigator and then assessed in Data Safety and Monitory Board regular meetings.
 
Arm/Group Title HIV + on Vitamin D Control Dose HIV+ on Vitamin D Supplementation Dose HIV - on Vitamin D Control Dose HIV- on Vitamin D Supplementation Dose
Hide Arm/Group Description HIV+ receiving vitamin D control dose ( low dose: 18,000 IU per month) HIV+ receiving vitamin D supplementation doses (medium dose of 60,000 IU per month or higher dose of 120,000 IU/month) HIV negative patients receiving vitamin D control dose (low dose of 18,000 IU per month) HIV negative patients receiving vitamin D supplementation doses (medium dose of 60,000 IU per month or higher dose of 120,000 IU/month)
All-Cause Mortality
HIV + on Vitamin D Control Dose HIV+ on Vitamin D Supplementation Dose HIV - on Vitamin D Control Dose HIV- on Vitamin D Supplementation Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/66 (0.00%)   0/58 (0.00%)   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
HIV + on Vitamin D Control Dose HIV+ on Vitamin D Supplementation Dose HIV - on Vitamin D Control Dose HIV- on Vitamin D Supplementation Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/66 (0.00%)   0/30 (0.00%)   0/58 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV + on Vitamin D Control Dose HIV+ on Vitamin D Supplementation Dose HIV - on Vitamin D Control Dose HIV- on Vitamin D Supplementation Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/66 (0.00%)   0/30 (0.00%)   0/58 (0.00%) 
Limitations to this study include the lack of adherence measures to study drug such as pill counts and the small sample size.
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
Name/Title: Dr Grace McComsey
Organization: University Hospitals Cleveland Medical Center
Phone: 216-844-2739
Responsible Party: Grace McComsey, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01523496     History of Changes
Other Study ID Numbers: 09-11-06
First Submitted: January 27, 2012
First Posted: February 1, 2012
Results First Submitted: October 24, 2017
Results First Posted: February 6, 2018
Last Update Posted: March 8, 2018