Calcium and Vitamin D Malnutrition in Elderly Women

NCT00352170 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1180

Last updated 2008-08-11

No results posted yet for this study

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

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00352170 on ClinicalTrials.gov