The Effect of Vitamin D and Calcium on Bone in Pediatric HIV
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Purpose
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:
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.
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
- 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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection Bone Mass |
Dietary Supplement: cholecalciferol plus calcium carbonate |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Vitamin D and Calcium on Bone in Pediatric HIV |
- Total Body Bone Mineral Content [ Time Frame: Entry, 12 and 24 months ] [ Designated as safety issue: No ]
- Additional outcomes that will be evaluated include the effect of Vitamin D and calcium on serum and urine calcium and creatinine and markers of bone turnover [ Time Frame: Monthly for first year, and quarterly in year.Bone turnover measured at baseline, 2. 3, 6, 12, and 24 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 59 |
| Study Start Date: | July 2003 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Oral cholecalciferol (100,000 IU) administered orally every 60 days plus calcium carbonate (1 gram)given daily
|
Dietary Supplement: cholecalciferol plus calcium carbonate
oral calciferol 100,000 IU by mouth bimonthly and calcium carbonate (1 gr) by mouth daily
Other Name: Vitamin D3
|
|
Placebo Comparator: B
Double placebo
|
Dietary Supplement: cholecalciferol plus calcium carbonate
oral calciferol 100,000 IU by mouth bimonthly and calcium carbonate (1 gr) by mouth daily
Other Name: Vitamin D3
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 6 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject, parent, or legal guardian able and willing to provide informed consent/assent.
Subject able and willing to comply with requirements of study HIV-infected subjects must have diagnosis confirmed with one or more of the following tests: 1) HIV DNA Polymerase chain reaction or HIV culture performed at any age; 2) Age >18 months, licensed ELISA with confirmatory Western Blot.
Exclusion Criteria:
Patients with history of atraumatic fractures, known renal or liver disease, known malabsorption syndrome, or inflammatory bowel disease.
Use of corticosteroids, exculding inhaled steroids (current or within past 6 months) Current use of anticonvulsant drug Daily cigarette smoking Daily consumption of alcohol containing beverages Current use of tenofovir
Contacts and Locations| United States, New York | |
| St.Luke's-Roosevelt Hospital Cener | |
| New York, New York, United States, 10025 | |
| Principal Investigator: | Stephen M Arpadi, MD, MS | St.Luke-Roosevelt Hospital Center, Columbia University, college of Physicians & Surgeons, mailman School of Public Health |
More Information
No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Stephen Arpadi, St.Luke's-Roosevelt Hospital Center& Columbia University |
| ClinicalTrials.gov Identifier: | NCT00724178 History of Changes |
| Other Study ID Numbers: | DK63666 (completed) |
| Study First Received: | July 28, 2008 |
| Last Updated: | January 14, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
Pediatric HIV infection, bone mineral content, bone mineral density, Vitamin D, calcium Dual x-ray absorptiometry |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Calcium, Dietary |
Cholecalciferol Vitamin D Ergocalciferols Calcium Carbonate Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013