Osteoporosis, OsteopeniaNCT03367585
Effects of Vitamin D Supplementation in Muscle Strength and Balance Training
A study testing Physical exercise + Vitamin D3 and Physical exercise in people with Osteoporosis, Osteopenia and Osteoporosis, Postmenopausal, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Introduction: In Brazil, a person who is sixty years old or more is considered elderly. The incidence of osteoporosis and osteopenia has been increasing, as have fractures resulting from falls. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Osteoporosis, Osteopenia, Osteoporosis, Postmenopausal
- What is being tested?
- Physical exercise + Vitamin D3 and Physical exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2018to 22 Apr 2020
- Phase
- Interventional
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 60 years;
- Osteoporosis or osteopenia (bone mineral density lower than -1.5 standard deviations of the T-score);
- Present hypovitaminosis D (<30 nmol / L);
- Do not practice regular resistance exercise;
- Can not have an injury in lower limbs at least on the last three months,;
- Be able to perform independent gait without climbing for at least 100 meters;
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- Be independent in your daily life activities;
- Do not present restrictions for the practice of resistance exercises, including having performed a recent exercise test (maximum 6 months);
- Do not use medications such as estrogen's, diuretics, to improve bone mass;
- Do not use dietary supplements with vitamin D;
- Do not present hyperparathyroidism, diabetes, uncontrolled hypertension, hyperprolactinemia, hypercalciuria, renal lithiasis or elevated serum calcium.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vitamin D Supplementation in Muscle Strength and Postural Balance Training in Vulnerable Elderly Women
Introduction: In Brazil, a person who is sixty years old or more is considered elderly. The incidence of osteoporosis and osteopenia has been increasing, as have fractures resulting from falls. Vitamin D deficiency can cause muscular atrophy in type II fibers (fast contraction and strength), which can increase the risk of falls. The aging process produces reduction in the ability of postural control system to maintain postural balance, which may increase postural instability and consequently increase the elderly risk to falls. Objective: To evaluate if vitamin D supplementation associated with regular exercise in vulnerable older women improves muscle strength and postural balance in 12 weeks. Methods: This will be a randomized prospective clinical trial, double blind, placebo-controlled intervention. Will be part of the study 40 elderly women vulnerable, who meet the inclusion criteria and that will be coming from the community through calls made by radio and social network. The volunteer will undergoing to blood test, body composition and bone mineral density, Mini Mental State Examination, Geriatric Depressive Scale, Falls Efficacy Scale, WHOQOL-OLD and WHOQOL-BREF instruments, functional capacity tests (MiniBEST, Time up and Go, Chair Rising Test, Six-minute walk test), muscular strength assessment (isokinetic dynamometry, handgrip and 1RM test) and postural balance (AccSway force platform for static postural balance and NeuroCom's Balance Master for dynamic postural balance) before and after 12 weeks of intervention with vitamin D supplementation and resistance and postural balance exercise. The intervention that will be perform during the 12 weeks with a progressive resistance training program.
- Being tested
- Physical exercise + Vitamin D3, Physical exercise
- Keywords
- Supplementary Feeding, vitamin D, Muscle Strength, postural balance, exercise, aged
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise + Vitamin D3Dietary supplement
Strength exercise + Supplementation of vitamin D3 50,000 IU / week
Physical exerciseOther
Strength exercise
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group, which will supplement vitamin D3 50,000 IU / week, being in two capsules (25,000 IU / week each), Receives: Dietary Supplement: Physical exercise + Vitamin D3 |
| Placebo | Placebo comparator | The placebo group will inject two capsules of equal size, volume and coloration, composed of lactose, without the vitamin D3 supplement. Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural balance - semi static - change
Evaluation of postural balance - AccSway force platform for semi static postural. The arithmetic mean of the results was calculated from the three tests conducted under each condition, and was processed using the Balance Clinic software. The following parameters were used to measure the stability of the participants: medial-lateral and anteroposterior amplitude (cm), the mean velocity calculated from the total displacement of the center of pressure (COP) in all directions (cm/s), and the elliptical area encompassing 95% of the displacement from the COP (cm2). The following parameters were used to measure the stability of the participants: medial-lateral and anteroposterior amplitude (cm), the mean velocity calculated from the total displacement of the center of pressure (COP) in all directions (cm/s).
Measured: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Secondary outcomes (5)
Postural balance - dynamic - change
Evaluation of dynamic postural balance - The postural balance assessment (posturography) will be perform on the NeuroCom Balance Master® force platform system (NeuroCom International, Inc., Clackamas, OR, USA). The variables will be the mean sway speed (cm/s) on a stable surface and an unstable surface; and the mean sway in the anteropoterior direction and mediolateral (cm) direction at the same conditions. The variables will be the mean weight transfer index (%), mean movement time (s) and mean impact index.
Measured: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Muscular strength - Hand Grip - change
Evaluation of muscular strength improvement- hand grip strength (HGS). HGS assessment was performed using a Jamar hand dynamometer, measured in kilograms (kg), which is adopted by the American Society of Hand Therapists (ASHT).
Measured: This measure will be perform before and after the intervation (12 weeks strenght and potural balance exercise).
Muscular strength - Isokinetic dynamometry - change
Evaluation of muscular strength improvement - Isokinetic dynamometry will be use to determine knee extension and flexion strength using the Biodex Multi-Joint System 3 (Biodex MedicalTM, Shirley, NY, USA). The isokinetic variables used were maximum peak torque corrected for body weight (%), and total work (J).
Measured: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Muscular strength - 1 maximal repetition (RM)- change
Evaluation of muscular strength improvement - 1RM test. One-repetition maximum in weight training is the maximum amount of force that can be generated in one maximal contraction (kg).
Measured: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Body composition and bone mineral density - change
Evaluation of body composition (area=cm2; BMC=g and BMD=g/cm2) and bone mineral density (BMD=g/cm2; T-score)
Measured: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Feb 2018
- Primary completion1 Dec 2018
- Study completion22 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, OsteopeniaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective clinical trial, double-blind, placebo-controlled intervention
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367585
- Sponsor's protocol ID
- 306/15
- Status last verified
- Oct 2019
- First submitted
- 4 Dec 2017
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Supplementation in Muscle Strength and Postural Balance Training in Vulnerable Elderly Women
- ClinicalTrials.gov ID
- NCT03367585
- Acronym / sponsor ID
- 306/15
- Keywords
- Supplementary Feeding, vitamin D, Muscle Strength, postural balance, exercise, aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 8 Dec 2017 (actual)
- 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.
Introduction: In Brazil, a person who is sixty years old or more is considered elderly. The incidence of osteoporosis and osteopenia has been increasing, as have fractures resulting from falls. Vitamin D deficiency can cause muscular atrophy in type II fibers (fast contraction and strength), which can increase the risk of falls. The aging process produces reduction in the ability of postural control system to maintain postural balance, which may increase postural instability and consequently increase the elderly risk to falls. Objective: To evaluate if vitamin D supplementation associated with regular exercise in vulnerable older women improves muscle strength and postural balance in 12 weeks. Methods: This will be a randomized prospective clinical trial, double blind, placebo-controlled intervention. Will be part of the study 40 elderly women vulnerable, who meet the inclusion criteria and that will be coming from the community through calls made by radio and social network. The volunteer will undergoing to blood test, body composition and bone mineral density, Mini Mental State Examination, Geriatric Depressive Scale, Falls Efficacy Scale, WHOQOL-OLD and WHOQOL-BREF instruments, functional capacity tests (MiniBEST, Time up and Go, Chair Rising Test, Six-minute walk test), muscular strength assessment (isokinetic dynamometry, handgrip and 1RM test) and postural balance (AccSway force platform for static postural balance and NeuroCom's Balance Master for dynamic postural balance) before and after 12 weeks of intervention with vitamin D supplementation and resistance and postural balance exercise. The intervention that will be perform during the 12 weeks with a progressive resistance training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized prospective clinical trial, double-blind, placebo-controlled intervention
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Physical exercise + Vitamin D3The experimental group, which will supplement vitamin D3 50,000 IU / week, being in two capsules (25,000 IU / week each), |
| Placebo | Placebo comparator | Other: Physical exerciseThe placebo group will inject two capsules of equal size, volume and coloration, composed of lactose, without the vitamin D3 supplement. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > 60 years;
- Osteoporosis or osteopenia (bone mineral density lower than -1.5 standard deviations of the T-score);
- Present hypovitaminosis D (<30 nmol / L);
- Do not practice regular resistance exercise;
- Can not have an injury in lower limbs at least on the last three months,;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Physical exercise + Vitamin D3Strength exercise + Supplementation of vitamin D3 50,000 IU / week | Dietary supplement | Experimental |
| Physical exerciseStrength exercise | Other | Placebo |
Primary outcome
Postural balance - semi static - change
Time frame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Evaluation of postural balance - AccSway force platform for semi static postural. The arithmetic mean of the results was calculated from the three tests conducted under each condition, and was processed using the Balance Clinic software. The following parameters were used to measure the stability of the participants: medial-lateral and anteroposterior amplitude (cm), the mean velocity calculated from the total displacement of the center of pressure (COP) in all directions (cm/s), and the elliptical area encompassing 95% of the displacement from the COP (cm2). The following parameters were used to measure the stability of the participants: medial-lateral and anteroposterior amplitude (cm), the mean velocity calculated from the total displacement of the center of pressure (COP) in all directions (cm/s).
5 secondary outcomes
Postural balance - dynamic - change
Time frame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Muscular strength - Hand Grip - change
Time frame: This measure will be perform before and after the intervation (12 weeks strenght and potural balance exercise).
Muscular strength - Isokinetic dynamometry - change
Time frame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Muscular strength - 1 maximal repetition (RM)- change
Time frame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Body composition and bone mineral density - change
Time frame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
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 24 Apr 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise + Vitamin D3 and Physical exercise in people with Osteoporosis, Osteopenia and Osteoporosis, Postmenopausal, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 11 inclusion and 0 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 24 Apr 2020. 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 Brazil. 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.
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?
Postural balance - semi static - change (time frame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).). 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 24 Apr 2020.