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How Does Magnesium Status Influence Calcium Homeostasis?

NCT01593501 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2016-11-01

No results posted yet for this study

Summary

The investigators aim to recruit 60 women who have agreed to participate in an existing randomized, double-blind, placebo-controlled trial (Treatment of Vitamin D Insufficiency, HSC 2009-0055). In this trial, the investigators propose to evaluate the associations between magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis. The investigators will stratify 60 subjects in the sub-study, ensuring that approximately 20 subjects are randomized into each treatment arm (placebo, low-dose and high-dose vitamin D). The investigators already assess calcium homeostasis throughout the study by measuring bone mineral density, fractional calcium absorption, serum and urine calcium levels, among other tests. In the sub-study of 60 women, the investigators will evaluate whether habitually higher magnesium intake increases or decreases fractional calcium absorption. The investigators will evaluate the interplay between magnesium stores, vitamin D levels and serum parathyroid hormone levels. The investigators will directly assess magnesium stores using serum magnesium and 24-hour urine magnesium levels, and will measure magnesium absorption using the dual stable isotope approach.

Conditions

  • Magnesium Deficiency
  • Calcium Metabolism Disorders

Interventions

DIETARY_SUPPLEMENT

vitamin D3

pharmaceutical grade D3

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, M.D., M.S. · University of Wisconsin-Madison, Department of Medicine, Division of Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-08-31
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 NCT01593501 on ClinicalTrials.gov