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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age.
We are conducting a 4-year randomized, double-blind, placebo controlled trial of calcium or calcium with vitamin D supplementation. We randomly sampled the population of healthy, independent living women 55+ years in nine rural counties. We randomly assigned 1180 women to one of three groups: Group 1 receives calcium (1400 mg/d) and vitamin D placebo, Group 2 receives both calcium (1400 mg/d) and vitamin D (1100 IU/d) and Group 3 receives both placebos.
A full-service market research firm randomly selected telephone numbers from all households with listed numbers in the nine-county rural sample area. The firm continued calling until 1180 women were selected who met the inclusion and exclusion criteria and were willing to participate in a four year prospective study of calcium and vitamin D supplementation. The participants were enrolled into study between May 2000 and July 2001.
Participants have study visits every six months. Annually the following are performed: bone density scans, height and weight, brief medical history including medicine changes, fracture surveillance, and compliance with calcium and vitamin D. At baseline and end of study, spine x-rays and dietary recall were obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | calcium supplementation |
|
| 2 | Experimental | calcium and vitamin D3 supplementation |
|
| 3 | Experimental | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcium supplementation | Dietary Supplement | calcium carbonate 1500 mg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| fractures | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| changes in bone mass and density | 4 years | |
| changes in serum dihydroxyvitamin D | one year and four years | |
| changes in serum parathyroid hormone |
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Inclusion Criteria: healthy women ages 55 and older who were at least four years postmenopausal living independently in a nine-county rural area of Nebraska
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Exclusion Criteria:
1) chronic kidney disease, 2) Paget's metabolic bone disease, and 3) history of cancer except for superficial basal or squamous cell carcinoma of the skin and
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| Name | Affiliation | Role |
|---|---|---|
| Joan M Lappe, Ph.D | Creighton University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17556697 | Result | Lappe JM, Travers-Gustafson D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. Am J Clin Nutr. 2007 Jun;85(6):1586-91. doi: 10.1093/ajcn/85.6.1586. | |
| 24128439 | Derived | Zhou Y, Zhao LJ, Xu X, Ye A, Travers-Gustafson D, Zhou B, Wang HW, Zhang W, Lee Hamm L, Deng HW, Recker RR, Lappe JM. DNA methylation levels of CYP2R1 and CYP24A1 predict vitamin D response variation. J Steroid Biochem Mol Biol. 2014 Oct;144 Pt A:207-14. doi: 10.1016/j.jsbmb.2013.10.004. Epub 2013 Oct 12. |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D006962 | Hyperparathyroidism, Secondary |
| D058866 | Osteoporotic Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| calcium and vitamin D3 supplementation |
| Dietary Supplement |
calcium carbonate 1500 mg/day vitamin D3 1000 IU/day |
|
| Placebo | Dietary Supplement | calcium and vitamin D3 placebo |
|
| one year and four years |
| cancer | four years |
| Falls | four years |
| D009750 |
| Nutritional and Metabolic Diseases |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |