- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02327091
The Effect of Alfacalcidol on Muscle Strength in Elderly Indonesian Women : A Randomized Controlled Trial
December 29, 2014 updated by: Anugrahini, Indonesia University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
122
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jakarta
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Jakarta Pusat, Jakarta, Indonesia, 10430
- Division of Geriatrics, Department of Internal Medicine, University of Indonesia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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
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Active Comparator: alfacalcidol
One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo
|
One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of muscle strength in the group that received alfacalcidol compared to placebo
Time Frame: 12 weeks
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After 12 weeks of intervention, 88 subjects had the second muscle strength measurement
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Iin Anugrahini, Internal of Medicine, University of Indonesia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
January 28, 2013
First Submitted That Met QC Criteria
December 29, 2014
First Posted (Estimate)
December 30, 2014
Study Record Updates
Last Update Posted (Estimate)
December 30, 2014
Last Update Submitted That Met QC Criteria
December 29, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 269/PT02.FK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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