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Vitamin D HIV Study on Postmenopausal Women

NCT01375010 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2019-03-07

Study results available
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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.

Conditions

Interventions

DRUG

Vitamin D3

2000 mg QD

OTHER

Placebo

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

DRUG

Vitamin Supplements

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).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Elizabeth Shane, MD · Columbia University

  • Michael Yin, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2016-02-29
Completion
2016-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01375010 on ClinicalTrials.gov