The Effect of Alfacalcidol on Muscle Strength in Elderly Indonesian Women : A Randomized Controlled Trial

Phase 3

Completed

• Conditions: Muscle Weakness
• Interventions: Drug: alfacalcidol

• Registration Number: NCT02327091
• Lead Sponsor: Indonesia University

Brief Summary

The age-related increase in falls is strongly associated with a decline in muscle strength by the mechanism of sarcopenia. There has been great interest in developing approaches to counteract the effects of sarcopenia, and thereby reduce the age-related decline in muscle mass with vitamin D that have muscular effect. However, a limited number of studies demonstrate a vitamin D analog (alfacalcidol) increase in lower body muscle strength in adults with vitamin D deficiency. A double-blinded randomized controlled trial was conducted in order to determine the effect of alfacalcidol on the upper-body muscle strength in Indonesian elderly women in age group of 60 or more who had low handgrip strength.

Detailed Description

A total 122 elderly women were enrolled to this study. It was determined subjects with handgrip strength less than 22 kg and measured using handheld dynamometer. There were 95 subjects fulfilled the eligible criteria. These subjects were randomized into two groups, one group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo. Each subject was given calcium 500 mg/day. After 12 weeks of intervention, 88 subjects had the second muscle strength measurement (7 dropped out).

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Study First Submitted: 2013-01-28
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-29
• Last Update Submitted: 2014-12-29
• Study First Posted: 2014-12-30
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

Inclusion Criteria

• Elderly women in age group of 60 or more
• Subjects with handgrip strength less than or equal to 22 kg

Exclusion Criteria

• Hypercalcemia (serum calcium > 10.5 mg / dL)
• Can not understand instructions well (MMSE scale < 16)
• Depression (Geriatric Depression Scale> 10)
• Fracture, deformity, and pain with a visual analog scale (VAS) ≥ 4 on fingers and joints of the upper limb when the examination will be conducted
• Heart failure fc. III-IV or uncontrolled according to the New York Heart Association (NYHA)
• Neurological conditions (epilepsy, acute stroke, Parkinson's)
• Malignant hypertension (systolic blood pressure ≥ 200 mmHg and or diastolic blood pressure ≥ 120 mmHg)
• Blood malignancies and solid tumors
• Decreased function of the liver (cirrhosis, ALT increase above 2 times the upper normal limit )
• Refusing to follow the research / not willing controls

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alfacalcidol	alfacalcidol	One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo

Primary Outcome Measures

Name	Time	Method
Improvement of muscle strength in the group that received alfacalcidol compared to placebo	12 weeks	After 12 weeks of intervention, 88 subjects had the second muscle strength measurement

Trial Locations

Locations (1)

Division of Geriatrics, Department of Internal Medicine, University of Indonesia; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia