Calcium and Vitamin D Malnutrition in Elderly Women

Osteoporosis Clinical Trial

Official title:

Calcium and Vitamin D Malnutrition in Elderly Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352170
• Other study ID #: Ag14683
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2006
• Last updated: August 8, 2008
• Start date: May 2000
• Est. completion date: July 2005

Study information

• Verified date: August 2008
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1180
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Malnutrition
• Osteoporosis
• Secondary Hyperparathyroidism

Intervention

Dietary Supplement:
• calcium supplementation
calcium carbonate 1500 mg/day
• calcium and vitamin D3 supplementation
calcium carbonate 1500 mg/day vitamin D3 1000 IU/day
• Placebo
calcium and vitamin D3 placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	GlaxoSmithKline

References & Publications (1)

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. Erratum in: Am J Clin Nutr. 2008 Mar;87(3):794. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fractures		4 years	No
Secondary	changes in bone mass and density		4 years	No
Secondary	changes in serum dihydroxyvitamin D		one year and four years	No
Secondary	changes in serum parathyroid hormone		one year and four years	No
Secondary	cancer		four years	No
Secondary	Falls		four years	No