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Sponsors and Collaborators: |
National Institute on Aging (NIA) Office of Dietary Supplements (ODS) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00472823 |
The purpose of this study is to examine the effects of several doses of vitamin D on hormones related to bone, calcium absorption, bone density and muscle strength.
Condition | Intervention |
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Osteoporosis Aging |
Drug: Vitamin D3 Drug: Calcium Citrate (Citracal) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Determination of RDA for Vitamin D in Caucasian and African American Women |
Estimated Enrollment: | 320 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
400 IU per day
|
Drug: Vitamin D3
Orally for one year
Drug: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
|
2: Experimental
800 IU per day
|
Drug: Vitamin D3
Orally for one year
Drug: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
|
3: Experimental
1600 IU per day
|
Drug: Vitamin D3
Orally for one year
Drug: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
|
4: Experimental
2400 IU per day
|
Drug: Vitamin D3
Orally for one year
Drug: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
|
5: Experimental
3200 IU per day
|
Drug: Vitamin D3
Orally for one year
Drug: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
|
6: Experimental
4000 IU per day
|
Drug: Vitamin D3
Orally for one year
Drug: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
|
7: Experimental
4800 IU per day
|
Drug: Vitamin D3
Orally for one year
Drug: Calcium Citrate (Citracal)
Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily
|
The prevalence of osteoporosis is high in the United States, with about 10 million people over the age of 50 already having the disease and another 34 million at risk for developing it. Development of low-cost and effective strategies is important for preventing osteoporosis and reducing osteoporotic fractures. A simple inexpensive strategy to prevent osteoporosis is adequate nutrition with calcium and vitamin D. Serum 25OHD (25-hydroxyvitamin D) is now accepted as the objective measure of vitamin D nutrition. There is a growing understanding that serum 25OHD concentrations of at least 30-32 ng/ml are needed for optimal bone health at which serum parathyroid hormone (PTH) concentrations reach a minimum.
There are no systematic prospective dose response studies aimed at determining the optimum amount of vitamin D intake required to maintain optimum serum 25OHD levels in the population which will help in determining the estimated average requirement (EAR) and recommended dietary requirement (RDA) for vitamin D. More work to determine the RDA for vitamin D has been recommended by the Panel on Calcium and Related Nutrients of the Food and Nutrition Board. This study is aimed at filling the information gap by concentrating on the high risk group of postmenopausal women. We are testing the theory that increasing serum 25OHD to a level greater than 30 ng/ml will reduce serum PTH in the high risk group of vitamin D insufficient postmenopausal women with an adequate intake of calcium. We also believe that the dose of vitamin D that will achieve this level is approximately 4400IU per day, which is well above the suggested adequate intake of 400-600 ID recommended for the elderly.
In a one year double blind, randomized prospective clinical trial, we will examine the dose response effect of supplementation with different doses of vitamin D3 (400, 800, 1600, 2400, 3200, 4000, 4800IU/day) on the primary outcomes of serum 25OHD and PTH in 160 postmenopausal Caucasian and 160 African American women who have inadequate vitamin D levels in winter. We expect that the results from this study will add useful and important information about the RDA for vitamin D for postmenopausal women who are more susceptible to osteoporosis. The results from this study will also help in designing future clinical trials to study the effect of vitamin D, for example in preventing fractures, falls, cancer.
Progress: Caucasian enrollment completed July 2008; African American enrollment continuing.
Ages Eligible for Study: | 57 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: J Christopher Gallagher, MD, MRCP | 402-280-4518 | jcg@creighton.edu |
Contact: Shandelle Fertig, BA,MPH, CCRC | 402-280-5282 | sfertig@creighton.edu |
United States, Nebraska | |
Creighton University Medical Center | Recruiting |
Omaha, Nebraska, United States, 68131 | |
Contact: Shandelle Fertig, MPH,CCRC 402-280-5282 sfertig@creighton.edu | |
Contact: Abby McLaughlin 402-280-4198 AbbyMcLaughlin@creighton.edu | |
Principal Investigator: J Christopher Gallagher, MD | |
Sub-Investigator: Jane Meza, PhD | |
Sub-Investigator: Lynette Smith, MS |
Principal Investigator: | J C Gallagher, MD | Creighton University Medical Center |
Responsible Party: | Creighton University Medical Center ( J Christopher Gallagher, MD, MRCP ) |
Study ID Numbers: | AG0081, 1R01AG028168-01 |
Study First Received: | May 10, 2007 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00472823 |
Health Authority: | United States: Federal Government |
cholecalciferol vitamin D deficiency bone density |
dietary calcium hypercalcemia hypercalciuria |
Vitamin D Deficiency Calcium, Dietary Cholecalciferol Vitamin D Musculoskeletal Diseases Citric Acid |
Ergocalciferols Hypercalcemia Hypercalciuria Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |