Calcium and Vitamin D Malnutrition in Elderly Women

Sponsor

Creighton University (Other)

Overall Status

Completed

CT.gov ID

NCT00352170

Collaborator

GlaxoSmithKline (Industry)

1,180

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Secondary Hyperparathyroidism	Dietary Supplement: calcium supplementation Dietary Supplement: calcium and vitamin D3 supplementation Dietary Supplement: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

1180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Calcium and Vitamin D Malnutrition in Elderly Women

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Jul 1, 2005

Actual Study Completion Date :

Jul 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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
Experimental: 3 placebo	Dietary Supplement: Placebo calcium and vitamin D3 placebo

Arm

Intervention/Treatment

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

Experimental: 3

placebo

Dietary Supplement: Placebo

calcium and vitamin D3 placebo

Outcome Measures

Primary Outcome Measures

fractures [4 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

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