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

NCT02327091 | Completed Phase 3 DMC

• 1 other identifier: 269/PT02.FK
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness

Keywords

Alfacalcidol; Falls; Handgrip; Muscle strength; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

alfacalcidol DRUG

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

Also known as: BoneOne, C27H4402

alfacalcidol

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elderly women in age group of 60 or more
• Subjects with handgrip strength less than or equal to 22 kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

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

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Muscle Weakness; Sarcopenia

Interventions

alfacalcidol

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Atrophy; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Iin Anugrahini

  Internal of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: December 30, 2014
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

ID (1)