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Botswana Vitamin D Supplementation Study in HIV/AIDS

NCT02189902 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-07-15

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

4000 IU/d D3 over 12 weeks

DIETARY_SUPPLEMENT

7000 IU/d D3 over 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Virginia Stallings, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
51 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Botswana

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02189902 on ClinicalTrials.gov