Calcium and Vitamin D Malnutrition in Elderly Women
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.
|Osteoporosis Secondary Hyperparathyroidism||Dietary Supplement: calcium supplementation Dietary Supplement: calcium and vitamin D3 supplementation Dietary Supplement: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Calcium and Vitamin D Malnutrition in Elderly Women|
- fractures [ Time Frame: 4 years ]
- changes in bone mass and density [ Time Frame: 4 years ]
- changes in serum dihydroxyvitamin D [ Time Frame: one year and four years ]
- changes in serum parathyroid hormone [ Time Frame: one year and four years ]
- cancer [ Time Frame: four years ]
- Falls [ Time Frame: four years ]
|Study Start Date:||May 2000|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
Dietary Supplement: calcium supplementation
calcium carbonate 1500 mg/day
calcium and vitamin D3 supplementation
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352170
|Principal Investigator:||Joan M Lappe, Ph.D||Creighton University|