Status:
COMPLETED
The Effect of Vitamin D and Calcium on Bone in Pediatric HIV
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
HIV Infection
Bone Mass
Eligibility:
All Genders
6-16 years
Phase:
PHASE2
PHASE3
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 suppl...
Detailed Description
A.1.a. Introduction This is a prospective, randomized, double-blind clinical trial designed to evaluate the effect of 24 months of supplementation with vitamin D3 and calcium on bone mass accrual in H...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00724178
Start Date
July 1 2003
End Date
December 1 2006
Last Update
January 15 2010
Active Locations (1)
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1
St.Luke's-Roosevelt Hospital Cener
New York, New York, United States, 10025