Calcium and Vitamin D Malnutrition in Elderly Women

August 8, 2008 updated by: Creighton University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1180

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3
placebo
Dietary supplement: Placebo
calcium and vitamin D3 placebo
Experimental: 1
calcium supplementation
Dietary supplement: calcium supplementation
calcium carbonate 1500 mg/day
Experimental: 2
calcium and vitamin D3 supplementation
Dietary supplement: calcium and vitamin D3 supplementation
calcium carbonate 1500 mg/day vitamin D3 1000 IU/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fractures
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in bone mass and density
Time Frame: 4 years
4 years
changes in serum dihydroxyvitamin D
Time Frame: one year and four years
one year and four years
changes in serum parathyroid hormone
Time Frame: one year and four years
one year and four years
cancer
Time Frame: four years
four years
Falls
Time Frame: four years
four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Joan M Lappe, Ph.D, Creighton University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 12, 2006

First Posted (Estimate)

July 14, 2006

Study Record Updates

Last Update Posted (Estimate)

August 11, 2008

Last Update Submitted That Met QC Criteria

August 8, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ag14683

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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