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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00724178
First received: July 28, 2008
Last updated: January 14, 2010
Last verified: January 2010
  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:

  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.


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

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Total Body Bone Mineral Content [ Time Frame: Entry, 12 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724178

Locations
United States, New York
St.Luke's-Roosevelt Hospital Cener
New York, New York, United States, 10025
Sponsors and Collaborators
Investigators
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 August 27, 2014