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

NCT ID: NCT02327091

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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).

Conditions

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Muscle Weakness

Keywords

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Alfacalcidol Falls Handgrip Muscle strength Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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white rice flour capsule

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

alfacalcidol

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

Group Type ACTIVE_COMPARATOR

alfacalcidol

Intervention Type DRUG

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

Interventions

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alfacalcidol

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

Intervention Type DRUG

Other Intervention Names

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BoneOne, C27H4402

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Anugrahini

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iin Anugrahini

Role: PRINCIPAL_INVESTIGATOR

Internal of Medicine, University of Indonesia

Locations

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

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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269/PT02.FK

Identifier Type: -

Identifier Source: org_study_id