Calcium and Vitamin D Malnutrition in Elderly Women
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
fractures
4 years
No
Joan M Lappe, Ph.D
Principal Investigator
Creighton University
United States: Federal Government
Ag14683
NCT00352170
May 2000
July 2005
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