NCT00724178

Brief 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. 1.Determine the effect of vitamin D and calcium supplementation on bone mineral accrual in HIV-infected children.
  2. 2.Determine the effect of HIV infection and vitamin D and calcium supplementation on indices of mineral metabolism and markers of bone turnover.
  3. 3.Evaluate if vitamin D stores are a determinant of bone mass in HIV infected children and adolescents receiving HAART.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

3.1 years

First QC Date

July 28, 2008

Last Update Submit

January 14, 2010

Conditions

HIV InfectionBone Mass

Keywords

Pediatric HIV infection, bone mineral content, bone mineral density, Vitamin D, calcium Dual x-ray absorptiometry

Outcome Measures

Primary Outcomes (1)

  • Total Body Bone Mineral Content

    Entry, 12 and 24 months

Secondary Outcomes (1)

  • 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

    Monthly for first year, and quarterly in year.Bone turnover measured at baseline, 2. 3, 6, 12, and 24 months

Study Arms (2)

A

EXPERIMENTAL

Oral cholecalciferol (100,000 IU) administered orally every 60 days plus calcium carbonate (1 gram)given daily

Dietary Supplement: cholecalciferol plus calcium carbonate

B

PLACEBO COMPARATOR

Double placebo

Dietary Supplement: cholecalciferol plus calcium carbonate

Interventions

cholecalciferol plus calcium carbonateDIETARY_SUPPLEMENT

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

Also known as: Vitamin D3
AB

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.Luke's-Roosevelt Hospital Cener

New York, New York, 10025, United States

Location

Related Publications (1)

  • Arpadi SM, McMahon DJ, Abrams EJ, Bamji M, Purswani M, Engelson ES, Horlick M, Shane E. Effect of supplementation with cholecalciferol and calcium on 2-y bone mass accrual in HIV-infected children and adolescents: a randomized clinical trial. Am J Clin Nutr. 2012 Mar;95(3):678-85. doi: 10.3945/ajcn.111.024786. Epub 2012 Jan 18.

    PMID: 22258265DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

CholecalciferolCalcium Carbonate

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Stephen M Arpadi, MD, MS

    St.Luke-Roosevelt Hospital Center, Columbia University, college of Physicians & Surgeons, mailman School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 29, 2008

Study Start

July 1, 2003

Primary Completion

August 1, 2006

Study Completion

December 1, 2006

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

US(1)