How Does Magnesium Status Influence Calcium Homeostasis? - Full Text View

Purpose

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.

Condition	Intervention	Phase
Magnesium Deficiency Calcium Metabolism Disorders	Dietary Supplement: vitamin D3	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	How Does Magnesium Status Influence Calcium Homeostasis?

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Calcium Metabolic Disorders Minerals Vitamin D

Drug Information available for: Cholecalciferol Calcium Gluconate Vitamin D Magnesium

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Evaluate the associations between magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis. [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
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 Outcome Measures:

Does vitamin D therapy have a differential impact on calcium absorption that is dependent on magnesium stores? [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
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.
Assessing relationships between magnesium status and bone mineral density. [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
Evaluate how magnesium status impacts the relationship between vitamin D levels and parathyroid hormone levels. [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2012
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Dietary Supplement: vitamin D3 pharmaceutical grade D3 Other Name: Cholecalciferol
Active Comparator: Low dose vitamin D 800 IU vitamin D3 every day of an approximate 365-day treatment.	Dietary Supplement: vitamin D3 pharmaceutical grade D3 Other Name: Cholecalciferol
Placebo Comparator: 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.	Dietary Supplement: vitamin D3 pharmaceutical grade D3 Other Name: Cholecalciferol

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

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593501

Contacts

Contact: Karen E Hansen, M.D, M.S.	608-265-8162	keh@medicine.wisc.edu
Contact: Rachael E Johnson, B.S.	608-263-0517	hansenteam@medicine.wisc.edu

Locations

United States, Wisconsin
University of Wisconsin-Madison Hospital, Clinical Research Unit, Osteoporosis Research Center	Recruiting
Madison, Wisconsin, United States, 53705
Contact: Rachael E Johnson, B.S. 608-263-0517 hansenteam@medicine.wisc.edu
Principal Investigator: Karen E Hansen, M.D., M.S.

Sponsors and Collaborators

University of Wisconsin, Madison

National Institutes of Health (NIH)

National Institute on Aging (NIA)

Investigators

Principal Investigator:

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

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

More Information

Additional Information:

Hansen Research Team website This link exits the ClinicalTrials.gov site

Publications:

Rude RK, Singer FR, Gruber HE. Skeletal and hormonal effects of magnesium deficiency. J Am Coll Nutr. 2009 Apr;28(2):131-41. Review.

Blumenthal NC, Betts F, Posner AS. Stabilization of amorphous calcium phosphate by Mg and ATP. Calcif Tissue Res. 1977 Oct 20;23(3):245-50.

Posner AS, Betts F, Blumenthal NC. Role of ATP and Mg in the stabilization of biological and synthetic amorphous calcium phosphates. Calcif Tissue Res. 1977 May;22 Suppl:208-12.

Bergman C, Gray-Scott D, Chen JJ, Meacham S. What is next for the Dietary Reference Intakes for bone metabolism related nutrients beyond calcium: phosphorus, magnesium, vitamin D, and fluoride? Crit Rev Food Sci Nutr. 2009 Feb;49(2):136-44.

Krejs GJ, Nicar MJ, Zerwekh JE, Norman DA, Kane MG, Pak CY. Effect of 1,25-dihydroxyvitamin D3 on calcium and magnesium absorption in the healthy human jejunum and ileum. Am J Med. 1983 Dec;75(6):973-6.

Abrams SA, Wen JP. Methodologies for using stable isotopes to assess magnesium absorption and secretion in children. J Am Coll Nutr. 1999 Feb;18(1):30-5.

Hardwick LL, Jones MR, Brautbar N, Lee DB. Magnesium absorption: mechanisms and the influence of vitamin D, calcium and phosphate. J Nutr. 1991 Jan;121(1):13-23. Review.

Liu YM, Neal P, Ernst J, Weaver C, Rickard K, Smith DL, Lemons J. Absorption of calcium and magnesium from fortified human milk by very low birth weight infants. Pediatr Res. 1989 May;25(5):496-502.

Holloway L, Moynihan S, Abrams SA, Kent K, Hsu AR, Friedlander AL. Effects of oligofructose-enriched inulin on intestinal absorption of calcium and magnesium and bone turnover markers in postmenopausal women. Br J Nutr. 2007 Feb;97(2):365-72.

Abrams SA. Using stable isotopes to assess mineral absorption and utilization by children. Am J Clin Nutr. 1999 Dec;70(6):955-64. Review.

Jones JE, Schwartz R, Krook L. Calcium homeostasis and bone pathology in magnesium deficient rats. Calcif Tissue Int. 1980;31(3):231-8.

Schwartz R, Reddi AH. Influence of magnesium depletion on matrix-induced endochondral bone formation. Calcif Tissue Int. 1979 Nov;29(1):15-20.

Rude RK, Gruber HE, Norton HJ, Wei LY, Frausto A, Mills BG. Bone loss induced by dietary magnesium reduction to 10% of the nutrient requirement in rats is associated with increased release of substance P and tumor necrosis factor-alpha. J Nutr. 2004 Jan;134(1):79-85.

Rude RK, Gruber HE, Norton HJ, Wei LY, Frausto A, Kilburn J. Dietary magnesium reduction to 25% of nutrient requirement disrupts bone and mineral metabolism in the rat. Bone. 2005 Aug;37(2):211-9.

Boskey AL, Rimnac CM, Bansal M, Federman M, Lian J, Boyan BD. Effect of short-term hypomagnesemia on the chemical and mechanical properties of rat bone. J Orthop Res. 1992 Nov;10(6):774-83.

MILLER ER, ULLREY DE, ZUTAUT CL, BALTZER BV, SCHMIDT DA, HOEFER JA, LUECKE RW. MAGNESIUM REQUIREMENT OF THE BABY PIG. J Nutr. 1965 Jan;85:13-20.

Reginster JY, Strause L, Deroisy R, Lecart MP, Saltman P, Franchimont P. Preliminary report of decreased serum magnesium in postmenopausal osteoporosis. Magnesium. 1989;8(2):106-9.

Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT01593501 History of Changes
Other Study ID Numbers:	HSC #2011-0547, R01AG028739-01A2
Study First Received:	May 4, 2012
Last Updated:	January 16, 2013
Health Authority:	United States: Institutional Review Board United States: Federal Government

Keywords provided by University of Wisconsin, Madison:

vitamin D
cholecalciferol
bone mineral density
Magnesium deficiency
Calcium metabolism disorders

Additional relevant MeSH terms:

Calcium Metabolism Disorders
Magnesium Deficiency
Metabolic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D

Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 21, 2013