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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indonesia University
• Treatments: Alfacalcidol; Hydroxycholecalciferols

Criteria

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