Clinical trial NCT02189902: Botswana Vitamin D Supplementation Study in HIV/AIDS
Official title: Botswana Vitamin D Supplementation Study in HIV/AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Keywords: Vitamin D
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 51
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Virginia Stallings, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steenhoff AP, Schall JI, Samuel J, Seme B, Marape M, Ratshaa B, Goercke I, Tolle M, Nnyepi MS, Mazhani L, Zemel BS, Rutstein RM, Stallings VA. Vitamin D(3)supplementation in Batswana children and adults with HIV: a pilot double blind randomized controlled trial. PLoS One. 2015 Feb 23;10(2):e0117123. doi: 10.1371/journal.pone.0117123. eCollection 2015.