Calcium and Vitamin D Malnutrition in Elderly Women

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00352170
First received: July 12, 2006
Last updated: August 8, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Osteoporosis
Secondary Hyperparathyroidism
Dietary Supplement: calcium supplementation
Dietary Supplement: calcium and vitamin D3 supplementation
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Calcium and Vitamin D Malnutrition in Elderly Women

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • fractures [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in bone mass and density [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • changes in serum dihydroxyvitamin D [ Time Frame: one year and four years ] [ Designated as safety issue: No ]
  • changes in serum parathyroid hormone [ Time Frame: one year and four years ] [ Designated as safety issue: No ]
  • cancer [ Time Frame: four years ] [ Designated as safety issue: No ]
  • Falls [ Time Frame: four years ] [ Designated as safety issue: No ]

Enrollment: 1180
Study Start Date: May 2000
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352170

Sponsors and Collaborators
Creighton University
GlaxoSmithKline
Investigators
Principal Investigator: Joan M Lappe, Ph.D Creighton University
  More Information

Publications:
Responsible Party: Joan M. Lappe, Creighton University
ClinicalTrials.gov Identifier: NCT00352170     History of Changes
Other Study ID Numbers: Ag14683
Study First Received: July 12, 2006
Last Updated: August 8, 2008
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Creighton University:
calcium
vitamin D
secondary hyperparathyroidism
osteoporotic fractures

Additional relevant MeSH terms:
Osteoporosis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Malnutrition
Nutrition Disorders
Parathyroid Diseases
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 28, 2014