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The Effect of Vitamin D and Calcium on Bone in Pediatric HIV

NCT00724178 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2010-01-15

No results posted yet for this study

Summary

We have observed that vitamin D deficiency, as evidenced by low serum 25(OH)D concentrations, is common in children and adolescents with HIV infection. To determine whether vitamin D and calcium supplementation improve bone mineral content (BMC) and bone mineral density (BMD) in HIV-infected children and adolescents, we propose a double-blind, randomized, placebo-controlled trial comparing supplementation with oral vitamin D and calcium to placebo.

The specific aims of this project are to:

1. Determine the effect of vitamin D and calcium supplementation on bone mineral accrual in HIV-infected children.

We hypothesize that BMC and BMD will increase to a greater extent in HIV-infected children who receive supplementation with vitamin D and calcium. This hypothesis will be tested by comparing changes in BMC and BMD, measured by dual energy x-ray absorptiometry (DXA), after one and two years of treatment in HIV-infected children and adolescents receiving vitamin D and calcium supplementation compared to those receiving placebo.
2. Determine the effect of HIV infection and vitamin D and calcium supplementation on indices of mineral metabolism and markers of bone turnover.

We hypothesize that indices of mineral metabolism and markers of bone formation and resorption will return toward normal in HIV-infected children and adolescents who are randomized to receive vitamin D and calcium supplementation. We will test these hypotheses by comparing longitudinal changes in indices of mineral metabolism and bone turnover markers in HIV-infected children and adolescents receiving vitamin D and calcium supplement versus those receiving placebo
3. Evaluate if vitamin D stores are a determinant of bone mass in HIV infected children and adolescents receiving HAART.

We hypothesize that vitamin D stores, as assessed by serum 25-hydroxyvitamin D levels, are an important determinant of bone mass in HIV-infected children and adolescents receiving HAART. We will test this hypothesis by evaluating whether measurements of bone mass are associated with vitamin D stores, as measured by serum 25-hydroxyvitamin D levels and other indices of mineral metabolism, in treated HAART-treated HIV-infected children and adolescents.

Conditions

  • HIV Infection
  • Bone Mass

Interventions

DIETARY_SUPPLEMENT

cholecalciferol plus calcium carbonate

oral calciferol 100,000 IU by mouth bimonthly and calcium carbonate (1 gr) by mouth daily

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Stephen M Arpadi, MD, MS · St.Luke-Roosevelt Hospital Center, Columbia University, college of Physicians & Surgeons, mailman School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2006-08-31
Completion
2006-12-31

Countries

  • United States

Study Locations

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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 NCT00724178 on ClinicalTrials.gov