How Does Magnesium Status Influence Calcium Homeostasis?

Magnesium Deficiency Clinical Trial

Official title:

How Does Magnesium Status Influence Calcium Homeostasis?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593501
• Other study ID #: HSC #2011-0547
• Secondary ID: R01AG028739-01A2
• Status: Completed
• Phase: Phase 4
• First received: May 4, 2012
• Last updated: October 31, 2016
• Start date: May 2012
• Est. completion date: August 2014

Study information

• Verified date: October 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calcium Metabolism Disorders
• Magnesium Deficiency
• Metabolic Diseases

Intervention

Dietary Supplement:
• vitamin D3
pharmaceutical grade D3

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison Hospital, Clinical Research Unit, Osteoporosis Research Center	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hansen KE, Nabak AC, Johnson RE, Marvdashti S, Keuler NS, Shafer MM, Abrams SA. Isotope concentrations from 24-h urine and 3-h serum samples can be used to measure intestinal magnesium absorption in postmenopausal women. J Nutr. 2014 Apr;144(4):533-7. doi: 10.3945/jn.113.186767. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the associations between magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis.	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.	0-12 months	No
Secondary	Does vitamin D therapy have a differential impact on calcium absorption that is dependent on magnesium stores?	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.	0-12 months	No
Secondary	Assessing relationships between magnesium status and bone mineral density.		0-12 months	No
Secondary	Evaluate how magnesium status impacts the relationship between vitamin D levels and parathyroid hormone levels.		0-12 months	No

External Links

•   Hansen Research Team website