Botswana Vitamin D Supplementation Study in HIV/AIDS

NCT ID: NCT02189902

Last Updated: 2014-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-07-31

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).

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

4000 IU/d of D3 by mouth for 12 weeks

4000 IU/d of D3 by mouth for 12 weeks

Group Type: ACTIVE_COMPARATOR

4000 IU/d D3 over 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

7000IU/d of D3 by mouth for 12 weeks

7000IU/d of D3 by mouth for 12 weeks

Group Type: EXPERIMENTAL

7000 IU/d D3 over 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Interventions

4000 IU/d D3 over 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

7000 IU/d D3 over 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Virginia Stallings

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Virginia Stallings, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Princess Marina Hospital

Gaborone, , Botswana

Countries

Botswana

References

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.

Reference Type: DERIVED

PMID: 25706751 (View on PubMed)

Other Identifiers

812323

Identifier Type: -

Identifier Source: org_study_id