Muscle WeaknessPhase 3NCT02327091
The Effect of Alfacalcidol on Muscle Strength in Elderly Indonesian Women : A Randomized Controlled Trial
A Phase 3 study testing alfacalcidol in people with Muscle Weakness, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- alfacalcidol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteIndonesia
- Study dates
- Apr 2012to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly women in age group of 60 or more
- Subjects with handgrip strength less than or equal to 22 kg
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Division of Geriatrics, Department of Internal Medicine, University of Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: 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.
Read the 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).
- Conditions
- Muscle Weakness
- Being tested
- alfacalcidol
- Keywords
- Alfacalcidol, Falls, Handgrip, Muscle strength, Sarcopenia
- Medical subject headings
- Muscle Weakness, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfacalcidolDrug
Also called BoneOne, C27H4402
One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: alfacalcidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anugrahini, Universitas Indonesia
- Investigators
- Iin Anugrahini, Principal investigator, Internal of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327091
- Sponsor's protocol ID
- 269/PT02.FK
- Status last verified
- Dec 2014
- First submitted
- 28 Jan 2013
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Vitamin D Analog (Alfacalcidol) on Muscle Strength in Elderly Indonesian Women Who Have Low Handgrip Strength
- ClinicalTrials.gov ID
- NCT02327091
- Acronym / sponsor ID
- 269/PT02.FK
- Conditions
- Muscle Weakness
- Keywords
- Alfacalcidol, Falls, Handgrip, Muscle strength, Sarcopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: alfacalcidolOne group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elderly women in age group of 60 or more
- Subjects with handgrip strength less than or equal to 22 kg
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alfacalcidolAlso: BoneOne, C27H4402One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo | Drug | alfacalcidol |
Primary outcome
Improvement of muscle strength in the group that received alfacalcidol compared to placebo
Time frame: 12 weeks
After 12 weeks of intervention, 88 subjects had the second muscle strength measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
Related trials for Muscle Weakness
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
Stroke, Upper Extremity Paresis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iin Anugrahini principal investigator
Internal of Medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alfacalcidol in people with Muscle Weakness, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of muscle strength in the group that received alfacalcidol compared to placebo (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.