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

University of Indonesia (UI)

Status and phase

Completed

Phase 3

Conditions

Muscle Weakness

Treatments

Drug: alfacalcidol

Study type

Interventional

Funder types

Other

Identifiers

NCT02327091

269/PT02.FK

Details and patient eligibility

About

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.

Full 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).

Enrollment

122 patients

Sex

Female

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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