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Treatment of Vitamin D Insufficiency

NCT00933244 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2015-11-10

Study results available
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Summary

The purpose of this study is to answer the following questions: Does vitamin D increase calcium absorption, bone mass and muscle mass and function in women past menopause who have mildly low vitamin D levels? Do these benefits require prescription-strength vitamin D, or is an over the counter vitamin D dose enough?

Conditions

  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

High Dose Vitamin D3

Yellow gel-cap vitamin D3 at 50,000 International Units daily for 15 days then two times a month for 350 days. Daily white placebo pills.

DIETARY_SUPPLEMENT

Low Dose Vitamin D3

White gel-cap vitamin D3 at 800 International Units to take orally, daily for 365 days. Intermittent yellow placebo pills.

DIETARY_SUPPLEMENT

Placebo

Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days. White gel-cap placebo pills once daily for 365 days.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Karen E Hansen, MD, MS · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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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 NCT00933244 on ClinicalTrials.gov