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Trials / Completed

CompletedNCT01593501

How Does Magnesium Status Influence Calcium Homeostasis?

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
39 (actual)
Sponsor
University of Wisconsin, Madison · Academic / Other
Sex
Female
Age
30 Years – 75 Years
Healthy volunteers
Accepted

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.

Detailed description

Use of serum magnesium isotopes to measure fractional magnesium absorption Four day food diaries to assess magnesium intake Standard urine and serum chemistries for remaining labs as noted above

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTvitamin D3pharmaceutical grade D3

Timeline

Start date
2012-05-01
Primary completion
2013-08-01
Completion
2014-08-01
First posted
2012-05-08
Last updated
2016-11-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01593501. Inclusion in this directory is not an endorsement.