Botswana Vitamin D Supplementation Study in HIV/AIDS

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Completed

CT.gov ID

NCT02189902

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal is to determine the vit D supplementation dose that safely results in optimal serum vitamin D (25D) concentrations in HIV-infected children and adults living in Botswana. To do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).

Condition or Disease	Intervention/Treatment	Phase
HIV	Dietary Supplement: 4000 IU/d D3 over 12 weeks Dietary Supplement: 7000 IU/d D3 over 12 weeks	Phase 3

Detailed Description

Many people living with HIV/AIDS in African countries are vit D deficient or insufficient. Vit D deficiency in HIV/AIDS may be due to low dietary vit D intake, increased requirements, malabsorption, specific drug therapies (antiretrovirals, in particular), reduced outdoor physical activity, reduced vit D synthesis from UV light exposure in dark skin pigmented individuals, or unknown HIV-associated factors. Vit D deficiency likely contributes to abnormal immune status and increased inflammatory state, and to poor growth, bone, and muscle function, and may contribute to risk for tuberculosis (TB) infection. The goal is to determine the vit D supplementation dose that safely results in optimal serum 25D concentrations in HIV-infected children and adults living in Botswana.

To do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Botswana Vitamin D Supplementation Study in HIV/AIDS

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 4000 IU/d of D3 by mouth for 12 weeks 4000 IU/d of D3 by mouth for 12 weeks	Dietary Supplement: 4000 IU/d D3 over 12 weeks
Experimental: 7000IU/d of D3 by mouth for 12 weeks 7000IU/d of D3 by mouth for 12 weeks	Dietary Supplement: 7000 IU/d D3 over 12 weeks

Arm

Intervention/Treatment

Active Comparator: 4000 IU/d of D3 by mouth for 12 weeks

4000 IU/d of D3 by mouth for 12 weeks

Dietary Supplement: 4000 IU/d D3 over 12 weeks

Experimental: 7000IU/d of D3 by mouth for 12 weeks

7000IU/d of D3 by mouth for 12 weeks

Dietary Supplement: 7000 IU/d D3 over 12 weeks

Outcome Measures

Primary Outcome Measures

To test the efficacy of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to replete vit D status (achieving a minimum serum 25D concentration of 32 ng/mL). [12 weeks]
To test two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to assess 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL.
To test the safety of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS as determined by serum calcium. [12 weeks]
To test two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to assess safety as determined by serum calcium.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 51 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

HIV infection
Ages 5.0 to 50.9 y
In usual state of good health
Subject and/or family commitment to the 12-week study

Exclusion Criteria:

Other chronic health conditions unrelated to HIV/AIDS that may affect nutritional status
Use of vit D supplementation above 400 IU/d

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Marina Hospital	Gaborone		Botswana	0000

Sponsors and Collaborators

Children's Hospital of Philadelphia

Investigators

Principal Investigator: Virginia Stallings, MD, Children's Hospital of Philadelphia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Virginia Stallings, Professor of Pediatrics, Children's Hospital of Philadelphia

ClinicalTrials.gov Identifier:

NCT02189902

Other Study ID Numbers:

812323

First Posted:

Jul 15, 2014

Last Update Posted:

Jul 15, 2014

Last Verified:

Jul 1, 2014

Keywords provided by Virginia Stallings, Professor of Pediatrics, Children's Hospital of Philadelphia

Vitamin D

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome

HIV Infections

Study Results

No Results Posted as of Jul 15, 2014