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| Tracking Information | |||||
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| First Received Date ICMJE | June 28, 2006 | ||||
| Last Updated Date | December 12, 2008 | ||||
| Start Date ICMJE | July 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00346658 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Magnesium Supplementation to Prevent Bone Loss | ||||
| Official Title ICMJE | Magnesium Supplementation to Prevent Bone Loss | ||||
| Brief Summary | Extreme magnesium deficiency is known to have an impact on the synthesis, secretion and/or action of calcium regulating hormones. Many older adults are at risk for less severe magnesium deficiency, since the majority of adults receive less than the Recommended Daily Allowance of magnesium. We hypothesize that magnesium supplementation will have a beneficial effect on calcium regulating hormones and markers of bone turnover. |
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| Detailed Description | This is a 12 month randomized, double-blind, placebo-controlled study of magnesium supplementation. Our hypothesis was that magnesium supplementation would decrease bone turnover markers and alter calcium-regulating hormones: parathyroid hormone and 1, 25 dihydroxyvitamin D. Male and female adults over 55 without with a T-score at the hip above -2 are randomized to magnesium 250 mg BID or identical placebo BID. At baseline, all participants had a bone mineral density (BMD) by DXA scan at the hip and spine, blood biomarkers of bone resorption and formation, and calcium regulating hormones. Participants were followed for 12 months, with repeat measurement of calcium regulating hormones and bone turnover markers. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Osteoporosis | ||||
| Intervention ICMJE | Drug: magnesium | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 74 | ||||
| Completion Date | September 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 55 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00346658 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | RR16047, 5 K23 RR016047 | ||||
| Study Sponsor ICMJE | University of Tennessee | ||||
| Collaborators ICMJE | National Center for Research Resources (NCRR) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Tennessee | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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