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

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.

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Key information

Conditions

Muscle Weakness Atrophy Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Division of Geriatrics, Department of Internal Medicine, University of Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alfacalcidol

Drug

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

Other names: BoneOne, C27H4402

Primary outcomes

Improvement of muscle strength in the group that received alfacalcidol compared to placebo

Time frame: 12 weeks

After 12 weeks of intervention, 88 subjects had the second muscle strength measurement

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Dec 30, 2014
Registry last updated: Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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