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
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Division of Geriatrics, Department of Internal Medicine, University of Indonesia | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
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 |
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