CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 85 enrolled
Drug / intervention
Vitamin D3 +2 moredrug
Likely dose
Vitamin D3 2000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01375010
NCT01375010Phase 2Completed
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The Effect of Vitamin D Repletion on Postmenopausal Women With HIV

Columbia University·interventional·Posted Jun 17, 2011·Updated Mar 7, 2019

In Brief

A Phase 2 clinical trial evaluating Vitamin D3, Placebo, and 1 other intervention for HIV. Completed, enrolled 85 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the effects of vitamin D on measures of bone health and immune function in HIV infected postmenopausal women. The investigators prior research with this population revealed that low vitamin D levels are very common. Prior research with this population also revealed that Vitamin D is necessary for the body to absorb calcium and is important for the health of the bones. When vitamin D levels are low, there are increased risks of bone loss, muscle weakness, falls and fractures. Low levels of vitamin D have also been associated with impaired immune function. This study will help us learn whether two different doses of vitamin D will improve bone health and immune function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2011
Enrollment StartJan 1, 2011
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 15.0 years ago

Interventions

Vitamin D3drug

2000 mg QD

Placeboother

An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.

Vitamin Supplementsdrug

Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).