The Effect of Alfacalcidol on Muscle Strength in Elderly... | NCT02327091

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

NCT02327091

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Dec 30, 2014Estimated

Enrollment

122Actual

Phase

Phase 3

Conditions

Muscle Weakness

Interventions

alfacalcidol

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jan 28, 2013

First Submission Date that Met QC Criteria

Dec 29, 2014

First Posted Date

Dec 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
white rice flour capsule	Placebo Comparator	One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo for 12 weeks
alfacalcidol	Active Comparator	One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo	Drug: alfacalcidol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
alfacalcidol	Drug	One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo	alfacalcidol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iin Anugrahini	Internal of Medicine, University of Indonesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Geriatrics, Department of Internal Medicine, University of Indonesia		Jakarta Pusat	Jakarta Special Capital Region	10430	Indonesia

Condition Browse Module

MeSH Terms

ID	Term
D018908	Muscle Weakness
D055948	Sarcopenia

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations

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