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How Does Magnesium Status Influence Calcium Homeostasis?

NCT ID: NCT01593501

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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

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Magnesium Deficiency Calcium Metabolism Disorders

Keywords

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vitamin D cholecalciferol bone mineral density Magnesium deficiency Calcium metabolism disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High dose vitamin D

50,000 IU vitamin D3 every 15 days, with a loading dose of 50,000 IU per day for the first 15 days of an approximate 365-day treatment.

Group Type ACTIVE_COMPARATOR

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

pharmaceutical grade D3

Low dose vitamin D

800 IU vitamin D3 every day of an approximate 365-day treatment.

Group Type ACTIVE_COMPARATOR

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

pharmaceutical grade D3

Placebo

A pill that looks like the low/high dose vitamin D pills, but contains no vitamin D. Given to preserve the double-blind nature of the study.

Group Type PLACEBO_COMPARATOR

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

pharmaceutical grade D3

Interventions

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vitamin D3

pharmaceutical grade D3

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cholecalciferol

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen E Hansen, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin-Madison, Department of Medicine, Division of Rheumatology

Locations

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

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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. Epub 2014 Feb 5.

Reference Type BACKGROUND
PMID: 24500940 (View on PubMed)

Other Identifiers

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R01AG028739-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC #2011-0547

Identifier Type: -

Identifier Source: org_study_id