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Calcium and Vitamin D Malnutrition in Elderly Women

Phase 3
55 Years
Not Enrolling
Osteoporosis, Secondary Hyperparathyroidism

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Trial Information

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

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.

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


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


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Joan M Lappe, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Creighton University


United States: Federal Government

Study ID:




Start Date:

May 2000

Completion Date:

July 2005

Related Keywords:

  • Osteoporosis
  • Secondary Hyperparathyroidism
  • calcium
  • vitamin D
  • secondary hyperparathyroidism
  • osteoporotic fractures
  • Hyperparathyroidism
  • Hyperparathyroidism, Secondary
  • Osteoporosis
  • Malnutrition