Botswana Vitamin D Supplementation Study in HIV/AIDS

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Phase 3

Conditions: HIV

Treatments: Dietary Supplement: 4000 IU/d D3 over 12 weeks; Dietary Supplement: 7000 IU/d D3 over 12 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT02189902

812323

Details and patient eligibility

About

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).

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 5 to 51 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

4000 IU/d of D3 by mouth for 12 weeks

Active Comparator group

Description:

4000 IU/d of D3 by mouth for 12 weeks

Treatment:

Dietary Supplement: 4000 IU/d D3 over 12 weeks

7000IU/d of D3 by mouth for 12 weeks

Experimental group

Description:

7000IU/d of D3 by mouth for 12 weeks

Treatment:

Dietary Supplement: 7000 IU/d D3 over 12 weeks