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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-

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HIV+ With Vit D Supplementation 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+ Young Adults With Vitamin D Control Dose HIV+ receiving Vitamin D low dose: 18,000 IU per month
HIV - With Vitamin D Supplementation 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 - With Vitamin D Control Dose HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month

Participant Flow:   Overall Study
    HIV+ With Vit D Supplementation   HIV+ Young Adults With Vitamin D Control Dose   HIV - With Vitamin D Supplementation   HIV - With Vitamin D Control Dose
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



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
HIV+ With Vit D Supplementation 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+ Young Adults With Vitamin D Control Dose HIV+ receiving Vitamin D low dose: 18,000 IU per month
HIV - With Vitamin D Supplementation 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 - With Vitamin D Control Dose HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month
Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 66   36   58   30   190 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 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 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
         
United States   66   36   58   30   190 


  Outcome Measures

1.  Primary:   Changes in Serum 25(OH)D3 Levels   [ Time Frame: 6 months ]

2.  Secondary:   Changes in Vitamin D Binding Protein (VDBP)   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations to this study include the lack of adherence measures to study drug such as pill counts and the small sample size.


  More Information

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
e-mail: Grace.McComsey@UHhospitals.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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