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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02327091
Other study ID # 269/PT02.FK
Secondary ID
Status Completed
Phase Phase 3
First received January 28, 2013
Last updated December 29, 2014
Start date April 2012
Est. completion date December 2012

Study information

Verified date December 2014
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority Indonesia: Departement Kesehatan (Department of Health)
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Indonesia Division of Geriatrics, Department of Internal Medicine, University of Indonesia Jakarta Pusat Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

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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