Calcium and Vitamin D Malnutrition in Elderly Women

Phase 3

Completed

• Conditions: Osteoporosis; Secondary Hyperparathyroidism
• Interventions: Dietary Supplement: calcium supplementation; Dietary Supplement: calcium and vitamin D3 supplementation; Dietary Supplement: Placebo

• Registration Number: NCT00352170
• Lead Sponsor: Creighton University

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2006-07-12
• Study First Submitted QC: 2006-07-12
• Study First Posted: 2006-07-14
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-08
• Last Update Posted: 2008-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	calcium supplementation	calcium supplementation
2	calcium and vitamin D3 supplementation	calcium and vitamin D3 supplementation
3	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
fractures	4 years

Secondary Outcome Measures

Name	Time	Method
changes in bone mass and density	4 years
changes in serum dihydroxyvitamin D	one year and four years
changes in serum parathyroid hormone	one year and four years
cancer	four years
Falls	four years