SarcopeniaNCT00986596
A Pilot Study of the Impact of Vitamin D3 on Muscle Performance in Elderly Women
A study testing vitamin D3 in people with Sarcopenia and Falls, run by Tufts University at 1 site in United States.
Trial summary
The purpose of the study is to investigate the effect of vitamin D on muscle tissue and physical performance. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Sarcopenia, Falls
- What is being tested?
- vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Feb 2011
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 and older
- 25 (OH)D levels >22.5 nmol/l or <60 nmol/l
- Women must have a composite physical performance score of ≤ 9 out of a possible score of 12.
- Subjects must agree not to change their usual level of physical activity or change the amount of calcium and vitamin D supplement they use for the duration of the study.
- If they are taking calcium supplements, they must agree to take the supplement any time after lunch.
Who cannot join
- General:
- Total calcium intake >1000mg daily on the prescreening questionnaire.
- More than 400 IU daily of supplemental vitamin D on the prescreening questionnaire.
- A screening 25(OH)D level > 60 nmol/ L.
- Screening 24-hour urine calcium > 275 mg.
- An abnormal serum calcium.
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- Travel to latitude <35 degrees N within 2 months of the time of enrollment; plans to travel to latitude <35 degrees N during the 4-month study, with the likelihood of tanning (e.g. appreciable sun exposure without sun screen).
- Greater than 2 drinks of alcohol a day.
- Medications:
- Bone active drugs such as bisphosphonates, estrogen, calcitonin, teriparatide
- Diuretics
- Oral glucocorticoids in the last month
- Phosphates in the last week
- Lithium
- Cod liver oil
- Total parenteral nutrition
- Calcium containing antacids
- Coumadin or other prescribed anticoagulants
- Diseases:
- Active thyroid disease - unstable levothyroxine dose
- Parathyroid disease
- Sarcoidosis
- Fracture of the foot, leg, or hip in the last year
- Renal stone < 5 years
- Alkaline phosphatase > 10% above the upper limit of normal
- Pancreatitis
- Active malignancy (other than basal cell cancer of the skin) or cancer therapy in the last year
- Uncontrolled arrhythmia in last year
- Malabsorption
- Use of a walker or wheelchair (3-post cane okay)
- Nasal oxygen use
- Must have a basic mobility level of walking 4 meters
- Hemiplegia
- Tuberculosis
- Type 1 Diabetes mellitus or unstable type 2 diabetes mellitus (fasting blood glucose >130 mg/dL)
- Other abnormality in screening labs, at the discretion of the study physician
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
The purpose of the study is to investigate the effect of vitamin D on muscle tissue and physical performance.
Read the detailed description
The investigators have recently observed that among healthy women age 65 and older who participated in a placebo-controlled vitamin D and calcium intervention trial, those treated with supplements had a lower risk of falling than those in the placebo group. Vitamin D receptors (VDRs) are present in muscle tissue and are thought to mediate the favorable effects of vitamin D on muscle performance. Vitamin D insufficiency is common particularly in the elderly and supplementation with a relatively high dose of vitamin D may be a useful approach for improving muscle performance and potentially lowering the risk of falling in sedentary older women and other high-risk populations.
The investigators will aim to study women, age 65 and older, with 25(OH)D levels below 60 nmol/l in a double-blind, 4-month randomized controlled pilot study. Eligible subjects will be randomized to treatment with 4000 IU per day of vitamin D3 or placebo. Blood and 24 hour urine will be measured at the beginning and end of the study as outlined in the intervention and measurement schedule below. In addition, a safety random spot urine will be analyzed for calcium and creatinine on day 30. Muscle performance measures will be measured and muscle biopsies will be performed at the beginning and end of the study.
- Conditions
- Sarcopenia, Falls
- Being tested
- vitamin D3, Placebo
- Keywords
- vitamin D, skeletal muscle, vitamin D receptor
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Dietary supplement
4000 IU once daily by mouth for 4 months
PlaceboDietary supplement
microcrystalline cellulose capsule p.o. daily (identical to vitamin D capsule)
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3 | Active comparator | vitamin D3 capsule 4000 IU p.o. daily Receives: Dietary Supplement: vitamin D3 |
| placebo | Placebo comparator | microcrystalline cellulose capsule p.o. daily (identical to vitamin D capsule) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define and compare changes in size and number of type II muscle fibers in response to 4 months of treatment with 4000 IU of vitamin D3 per day or placebo in older women with low-normal 25(OH)D levels.
Measured: 4 months
Secondary outcomes (3)
Define and compare vitamin D signaling in muscle biopsy specimens taken before and after the treatment.
Measured: 4 months
Define and compare changes in clinical measures of muscle performance before and after treatment
Measured: 4 months
Define and compare levels of bone turnover before and after treatment
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startOct 2006
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Boston Medical Center
- Responsible party
- Principal investigator, Bess Dawson-Hughes, Tufts University
- Investigators
- Bess Dawson-Hughes, MD, Principal investigator, Tufts UniversityLisa Ceglia, MD, Study director, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986596
- Sponsor's protocol ID
- 2450
- Other IDs
- 7528
- Status last verified
- Jan 2012
- First submitted
- 29 Sep 2009
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Impact of Vitamin D3 on Muscle Performance in Elderly Women
- ClinicalTrials.gov ID
- NCT00986596
- Acronym / sponsor ID
- 2450
- Conditions
- Sarcopenia, Falls
- Keywords
- vitamin D, skeletal muscle, vitamin D receptor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Boston Medical Center
- Study start
- Oct 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 30 Sep 2009 (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 purpose of the study is to investigate the effect of vitamin D on muscle tissue and physical performance.
Detailed description
The investigators have recently observed that among healthy women age 65 and older who participated in a placebo-controlled vitamin D and calcium intervention trial, those treated with supplements had a lower risk of falling than those in the placebo group. Vitamin D receptors (VDRs) are present in muscle tissue and are thought to mediate the favorable effects of vitamin D on muscle performance. Vitamin D insufficiency is common particularly in the elderly and supplementation with a relatively high dose of vitamin D may be a useful approach for improving muscle performance and potentially lowering the risk of falling in sedentary older women and other high-risk populations.
The investigators will aim to study women, age 65 and older, with 25(OH)D levels below 60 nmol/l in a double-blind, 4-month randomized controlled pilot study. Eligible subjects will be randomized to treatment with 4000 IU per day of vitamin D3 or placebo. Blood and 24 hour urine will be measured at the beginning and end of the study as outlined in the intervention and measurement schedule below. In addition, a safety random spot urine will be analyzed for calcium and creatinine on day 30. Muscle performance measures will be measured and muscle biopsies will be performed at the beginning and end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D3 | Active comparator | Dietary Supplement: vitamin D3vitamin D3 capsule 4000 IU p.o. daily |
| placebo | Placebo comparator | Dietary Supplement: Placebomicrocrystalline cellulose capsule p.o. daily (identical to vitamin D capsule) |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 65 and older
- 25 (OH)D levels >22.5 nmol/l or <60 nmol/l
- Women must have a composite physical performance score of ≤ 9 out of a possible score of 12.
- Subjects must agree not to change their usual level of physical activity or change the amount of calcium and vitamin D supplement they use for the duration of the study.
- If they are taking calcium supplements, they must agree to take the supplement any time after lunch.
Key exclusion criteria (36 listed)
- General:
- Medications:
- Diseases:
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 |
|---|---|---|
| vitamin D34000 IU once daily by mouth for 4 months | Dietary supplement | vitamin D3 |
| Placebomicrocrystalline cellulose capsule p.o. daily (identical to vitamin D capsule) | Dietary supplement | placebo |
Primary outcome
Define and compare changes in size and number of type II muscle fibers in response to 4 months of treatment with 4000 IU of vitamin D3 per day or placebo in older women with low-normal 25(OH)D levels.
Time frame: 4 months
3 secondary outcomes
Define and compare vitamin D signaling in muscle biopsy specimens taken before and after the treatment.
Time frame: 4 months
Define and compare changes in clinical measures of muscle performance before and after treatment
Time frame: 4 months
Define and compare levels of bone turnover before and after treatment
Time frame: 4 months
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 10 Jan 2012.
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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.
Bess Dawson-Hughes, MD principal investigator
Tufts University
Lisa Ceglia, MD study director
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D3 in people with Sarcopenia and Falls, run by Tufts University at 1 site in United States.
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 5 inclusion and 36 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 10 Jan 2012. 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 United States. 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?
Define and compare changes in size and number of type II muscle fibers in response to 4 months of treatment with 4000 IU of vitamin D3 per day or placebo in older women with low-normal 25(OH)D levels. (time frame: 4 months). 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 10 Jan 2012.