University of Wisconsin-Madison Hospital, Clinical Research Unit, Osteoporosis Research Center
Madison, Wisconsin, 53705, United States
NCT Number: NCT01593501
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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Notify Me30 year–75 year
Female
Interventional
Phase 4
Madison, Wisconsin, 53705, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
pharmaceutical grade D3
Other names: Cholecalciferol
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.
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.
Time frame: 0-12 months
Time frame: 0-12 months
University of Wisconsin, Madison
Other
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