Botswana Vitamin D Supplementation Study in HIV/AIDS

NCT02189902 | Completed Phase 3

• 1 other identifier: 812323
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV

Keywords

Vitamin D

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  12 weeks

• 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.

  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.

  12 weeks

Study Arms (2)

4000 IU/d of D3 by mouth for 12 weeks

ACTIVE COMPARATOR

4000 IU/d of D3 by mouth for 12 weeks

Dietary Supplement: 4000 IU/d D3 over 12 weeks

7000IU/d of D3 by mouth for 12 weeks

EXPERIMENTAL

7000IU/d of D3 by mouth for 12 weeks

Dietary Supplement: 7000 IU/d D3 over 12 weeks

Interventions

4000 IU/d D3 over 12 weeks DIETARY_SUPPLEMENT

4000 IU/d of D3 by mouth for 12 weeks

7000 IU/d D3 over 12 weeks DIETARY_SUPPLEMENT

7000IU/d of D3 by mouth for 12 weeks

Eligibility Criteria

• Age: 5 Years - 51 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Princess Marina Hospital

Gaborone, 0000, Botswana

Location

Related Publications (1)

• 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.

  PMID: 25706751 DERIVED

Study Officials

• Virginia Stallings, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 15, 2014
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

BO (1)