Calcium and Vitamin D Malnutrition in Elderly Women - Full Text View

Sponsors and Collaborators:	Creighton University GlaxoSmithKline
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00352170

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 III

MedlinePlus related topics: Calcium Cancer Dietary Supplements Fractures Osteoporosis

Drug Information available for: Calcium gluconate Vitamin D Ergocalciferol Calcium carbonate Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Calcium and Vitamin D Malnutrition in Elderly Women

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
1: Experimental calcium supplementation	Dietary Supplement: calcium supplementation calcium carbonate 1500 mg/day
2: Experimental calcium and vitamin D3 supplementation	Dietary Supplement: calcium and vitamin D3 supplementation calcium carbonate 1500 mg/day vitamin D3 1000 IU/day
3: Experimental 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

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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

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Contacts and Locations

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 of Results:

Lappe JM, Travers-Gustafson D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. Am J Clin Nutr. 2007 Jun;85(6):1586-91.

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

Keywords provided by Creighton University:

calcium
vitamin D
secondary hyperparathyroidism
osteoporotic fractures

Study placed in the following topic categories:

Cholecalciferol
Parathyroid Diseases
Fractures, Bone
Ergocalciferols
Osteoporosis
Endocrine System Diseases
Bone Diseases, Metabolic
Calcium Carbonate
Bone Diseases

Calcium, Dietary
Hyperparathyroidism, Secondary
Vitamin D
Malnutrition
Hyperparathyroidism
Musculoskeletal Diseases
Neoplasm Metastasis
Nutrition Disorders
Endocrinopathy

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Growth Substances
Vitamins

Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009