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Completed

NCT Number: NCT01593501

How Does Magnesium Status Influence Calcium Homeostasis?

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.

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Key information

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin-Madison Hospital, Clinical Research Unit, Osteoporosis Research Center

Madison, Wisconsin, 53705, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participants eligible for the study "Treatment of vitamin D insufficiency" are eligible for participation in the current sub-study

Exclusion criteria

  • identical to those covered in HSC #2009-0055

Treatment and study plan

Vitamin D3

Dietary Supplement

pharmaceutical grade D3

Other names: Cholecalciferol

Primary outcomes

  1. Evaluate the associations between magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis.

    Time frame: 0-12 months

    To evaluate relationships between magnesium intake and fractional magnesium absorption at baseline and 12 months, among 60 women participating in HSC Protocol 2009-0055, and to assess whether vitamin D therapy influences magnesium absorption among these women. We will also evaluate whether data collected from less than 72 hours of urine following tracer administration permits accurate assessment of fractional magnesium absorption.

Secondary outcomes

  1. Does vitamin D therapy have a differential impact on calcium absorption that is dependent on magnesium stores?

    Time frame: 0-12 months

    To assess whether vitamin D therapy has a differential impact on calcium absorption, depending on magnesium stores. We will use data from all subjects participating in HSC Protocol 2009-0055 to evaluate whether magnesium status is a co-factor in the change in calcium absorption that occurs with vitamin D therapy.

  2. Assessing relationships between magnesium status and bone mineral density.

    Time frame: 0-12 months

  3. Evaluate how magnesium status impacts the relationship between vitamin D levels and parathyroid hormone levels.

    Time frame: 0-12 months

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
May 8, 2012
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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