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

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT02327091

Collaborator

(none)

122

Enrollment

Location

Arms

Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Weakness	Drug: alfacalcidol	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: white rice flour capsule One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo for 12 weeks
Active Comparator: alfacalcidol One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo	Drug: alfacalcidol One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo Other Names: BoneOne, C27H4402

Arm

Intervention/Treatment

Placebo Comparator: white rice flour capsule

One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo for 12 weeks

Active Comparator: alfacalcidol

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

Drug: alfacalcidol

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

Other Names:

BoneOne, C27H4402

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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