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Sponsored by: |
University of Wisconsin, Madison |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00581828 |
The purpose is to perform a one-year study designed to assess whether treatment of hypovitaminosis D increases intestinal absorption of calcium, subsequent retention of calcium within bone, decreases bone turnover, and favorably impacts upon skeletal muscle mass, functional status, measures of physical function and quality of life. I hypothesize that treatment of hypovitaminosis D results in improved intestinal calcium absorption, greater retention of calcium within the bone reservoir and improved physical function, quality of life and muscle mass.
Condition | Intervention | Phase |
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Osteoporosis Osteopenia Vitamin D Deficiency Hypoparathyroidism Hypercalciuria Hypercalcemia |
Drug: Vitamin D |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | Does Treatment of Hypovitaminosis D Increase Calcium Absorption? |
Enrollment: | 20 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
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Drug: Vitamin D
50,000 IU po qd for 15 days and 50,000 IU po twice month for 10 months (until final study visit at one year)
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Up to 25 postmenopausal women with vitamin D insufficiency will participate in this one-year study. We will study the change in intestinal calcium absorption from baseline (vitamin D insufficiency) to follow up (vitamin D repletion and whether increased absorption results in subsequent increased retention of calcium within bone over the one-year interval as measured by bone densitometry. We will also study the effect of vitamin D repletion upon whole body muscle mass, quality of life and physical function.
A review of medical records and a screening visit will determine eligibility. Eligible and consenting subjects will present to the GCRC in the early morning and following baseline labs, will consume breakfast with a glass of orange juice enriched with a stable calcium isotope, and will receive 3 mg of another stable calcium isotope by intravenous injection. Over the next eight hours, blood will be taken a total of 9 more times and over the first 24 hours, all urine and stool will be collected for measurement of its calcium content.
Subsequently for the next five days, women will collect three urine specimens daily. Women will then receive vitamin D to treat vitamin D deficiency. Once vitamin D repletion is accomplished, all women will repeat their 24-hour GCRC visit and subsequent five-day urine collections. Women will maintain vitamin D repletion by taking a twice monthly tablet (50,000 IU) of vitamin D2. To confirm vitamin D repletion and safety over the full one year study, additional study visits will occur at 3, 6 and 12 months.
A bone density test at screening and twelve months will allow us to assess the effect of vitamin D repletion on whole body bone mass and skeletal mass. At each GCRC stay, 3, 6 and 12 months, women will complete questionnaires regarding quality of life and functional status and will perform the Timed Up and Go Test. Because we wish to maintain and confirm constant calcium intake throughout the one- year study, women will complete a calcium questionnaire at baseline, 3, 6 and 12 months.
With each subject's consent, we will collect one tube of blood and isolate its DNA, saving the DNA indefinitely within the locked GRECC Drezner/Blank Laboratory (5th Floor, VA Hospital). When sufficient knowledge is available regarding the pathophysiologic mechanisms whereby genetic polymorphisms impact calcium homeostasis, we will test for such DNA polymorphisms and relate genetic information with other data collected on calcium homeostasis.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Wisconsin | |
University of Wisconsin Hospital and Clinics | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Karen E Hansen, MD | University of Wisconsin School of Medicine and Public Health |
Responsible Party: | University of Wisconsin School of Medicine and Public Health ( Karen E Hansen, MD ) |
Study ID Numbers: | 2005-0159, 05-1235-02 |
Study First Received: | December 19, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00581828 |
Health Authority: | United States: Institutional Review Board |
Calcium Absorption Intestinal Absorption of Calcium Fractional Calcium Absorption Stable Calcium Isotopes |
Hypovitaminosis D Vitamin D Bone Mineral Density Physical Function |
Vitamin D Deficiency Cholecalciferol Parathyroid Diseases Metabolic Diseases Avitaminosis Ergocalciferols Hypercalcemia Osteoporosis Endocrine System Diseases Bone Diseases, Metabolic Bone Diseases Calcium, Dietary |
Signs and Symptoms Vitamin D Malnutrition Musculoskeletal Diseases Rickets Nutrition Disorders Hypercalciuria Water-Electrolyte Imbalance Endocrinopathy Hypoparathyroidism Metabolic disorder Deficiency Diseases |
Calcium Metabolism Disorders Urological Manifestations Growth Substances Vitamins |
Physiological Effects of Drugs Bone Density Conservation Agents Micronutrients Pharmacologic Actions |