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

Muscle Weakness Clinical Trial

Official title:

Phase 3 Study of Vitamin D Analog (Alfacalcidol) on Muscle Strength in Elderly Indonesian Women Who Have Low Handgrip Strength

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327091
• Other study ID #: 269/PT02.FK
• Status: Completed
• Phase: Phase 3
• First received: January 28, 2013
• Last updated: December 29, 2014
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis

Intervention

Drug:
• alfacalcidol
One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo

Locations

Country	Name	City	State
Indonesia	Division of Geriatrics, Department of Internal Medicine, University of Indonesia	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of muscle strength in the group that received alfacalcidol compared to placebo	After 12 weeks of intervention, 88 subjects had the second muscle strength measurement	12 weeks	Yes