Calcium and Vitamin D Malnutrition in Elderly Women
NCT00352170 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1180
Last updated 2008-08-11
Summary
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.
* A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets.
* A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.
Conditions
- Osteoporosis
- Secondary Hyperparathyroidism
Interventions
- DIETARY_SUPPLEMENT
-
calcium supplementation
calcium carbonate 1500 mg/day
- DIETARY_SUPPLEMENT
-
calcium and vitamin D3 supplementation
calcium carbonate 1500 mg/day vitamin D3 1000 IU/day
- DIETARY_SUPPLEMENT
-
Placebo
calcium and vitamin D3 placebo
Sponsors & Collaborators
- collaborator INDUSTRY
-
Creighton University
lead OTHER
Principal Investigators
-
Joan M Lappe, Ph.D · Creighton University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2000-05-31
- Primary Completion
- 2005-07-31
- Completion
- 2005-07-31
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