Effects of high dose vitamin D supplementation on muscle mass and muscle strength in frail elderly people

Completed

• Conditions: Hypovitaminosis D on muscle mass and strength; Musculoskeletal Diseases; Frailty, increasing muscle mass

• Registration Number: ISRCTN33988275
• Lead Sponsor: Erasmus Medical Centre (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Frail elderly people, aged greater than 65 years
2. Living in homes for the elderly
3. Serum vitamin D level less than 50 nmol/l
Added 07/04/2011:
4: Stable health (including no history of recurrent falling or recent fracture).

Exclusion Criteria

1. Not able to perform muscle strength measurements
2. History of kidney stones, renal insufficiency (less than 40%)
3. Primary hyperparathyroidism
4. Dementia (Mini Mental State Examination [MMSE] less than 20/30 points
5. Life expectancy less than six months
6. Neurodegenerative disorders (Parkinsons, Amyotrophic Lateral Sclerosis [ALS])
7. Use of the following medications:
7.1. Vitamin D
7.2. Bisphosphonates
7.3. Steroids

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in muscle strength (handgrip strength and quadriceps strength) between treatment and control group.

Secondary Outcome Measures

Name	Time	Method
1. Changes in mobility:<br>1.1. Timed up and go test<br>1.2. Walking distance<br>2. Quality of life (using the health assessment questionnaire)<br>3. Falls