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

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
alfacalcidol
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring Alfacalcidol, Falls, Handgrip, Muscle strength, Sarcopenia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Division of Geriatrics, Department of Internal Medicine, University of Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

white rice flour capsule

alfacalcidol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 28, 2013
Last Updated
December 29, 2014
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT02327091
Brief Title
The Effect of Alfacalcidol on Muscle Strength in Elderly Indonesian Women : A Randomized Controlled Trial
Official Title
Phase 3 Study of Vitamin D Analog (Alfacalcidol) on Muscle Strength in Elderly Indonesian Women Who Have Low Handgrip Strength
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
Alfacalcidol, Falls, Handgrip, Muscle strength, Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
white rice flour capsule
Arm Type
Placebo Comparator
Arm Description
One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo for 12 weeks
Arm Title
alfacalcidol
Arm Type
Active Comparator
Arm Description
One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo
Intervention Type
Drug
Intervention Name(s)
alfacalcidol
Other Intervention Name(s)
BoneOne, C27H4402
Intervention Description
One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo
Primary Outcome Measure Information:
Title
Improvement of muscle strength in the group that received alfacalcidol compared to placebo
Description
After 12 weeks of intervention, 88 subjects had the second muscle strength measurement
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iin Anugrahini
Organizational Affiliation
Internal of Medicine, University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Geriatrics, Department of Internal Medicine, University of Indonesia
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

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

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