Vitamin D DeficiencyVitDNCT01145703
Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly
A study testing RDA Vitamin D3 only, Vitamin D2/3 Repletion only and Vitamin D2/3 Repletion + AEX in people with Vitamin D Deficiency and Metabolic Syndrome, run by Baltimore VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of Vitamin D supplementation on the reasons (mechanisms) underlying the development of type 2 diabetes, metabolic syndrome (high blood pressure, cholesterol, diabetes, body weight/obesity), muscle weakness and wasting (sarcopenia), and impaired physical function… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Metabolic Syndrome
- What is being tested?
- RDA Vitamin D3 only, Vitamin D2/3 Repletion only and Vitamin D2/3 Repletion + AEX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Feb 2013
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-85 years of age
- Women must be post menopausal (absence of menses for 12 months or greater)
- 25-hydroxyvitamin D level below 20 ng/ml (50 nmol/L)
- BMI 25-45 kg/m2
- Non smoker ( non smoking for at least 12 months:cigarettes, cigars, pipes)
Who cannot join
- Symptomatic heart disease, CAD, CHF, or uncontrolled hypertension (BP over 180 mm HG) unless medically stabilized
- Currently being treated for active cancer
- Type 1 diabetes; insulin treatment for diabetes, poorly controlled diabetes, HgA1c >10%
- Allergic to lidocaine
- History of seizures or taking anti-seizure or anti convulsion medications
- Untreated dyslipidemia with National Cholesterol ATPIII 10 year cardiac risk score greater than 10% (www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.htm)
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- Taking oral steroids, warfarin or other medications interfering with fat/muscle metabolism that may not be safely discontinued temporarily for specific procedures (ie for 72 hours prior)
- Taking medication that interfere with ability to replete Vitamin D
- Abnormal liver function 2 times normal levels
- Abnormal renal function (BUN above 40 mg/dl, Cr above 1.8 mg/dl, CrCl<60mg/dl)
- Hypercalcemia (Ca>10.2mg/dl)
- Anemia HCT below 30 mg/dl, platelets below 100,000/cm3
- Chronic pulmonary disease (on supplemental O2)
- Other systemic disorders that are not medically treated and stable or affect the ability to absorb Vitamin D.
- MMSE below 24, dementia or unstable clinical depression by exam
- Abnormal response to exercise test (ST segment depression greater than 2mm, chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising BP above 240/120 mm HG, or other contraindications to exercise) *requires follow up treatment w/ primary MD for continued participation in study
- Aerobically trained with VO2max greater than 2 SD above age-adjusted mean
- Participant is, in the opinion of the investigator, unable to adhere to the study protocol due to medical or orthopedic conditions that limit ability to exercise or travel to the Baltimore VA for protocol procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vitamin D Supplementation With and With Out Exercise on Metabolic and Physical Consequences of Vitamin D Deficiency in the Elderly
The purpose of this study is to examine the effects of Vitamin D supplementation on the reasons (mechanisms) underlying the development of type 2 diabetes, metabolic syndrome (high blood pressure, cholesterol, diabetes, body weight/obesity), muscle weakness and wasting (sarcopenia), and impaired physical function (poor balance and walking) associated with vitamin D deficiency and osteopenia/osteoporosis (bone loss). The investigators obtain vitamin D through our diet and sunlight, and its conversion to active vitamins in the liver and kidneys promotes the intestinal absorption of calcium and regulation of bone growth. Therefore, vitamin D deficiency has been known for years to lead to weakened bones (osteopenia and osteoporosis). However, more recently, studies show vitamin D deficiency is associated with a number of other diseases, including type 2 diabetes, muscle weakness, frailty, and the metabolic syndrome. It has also been associated with cognitive impairment. Diabetes affects multiple organ systems including the heart, kidneys, musculoskeletal and nervous system. The possibility that vitamin D deficiency is linked to the development of type 2 diabetes, metabolic syndrome, muscle weakness and wasting (sarcopenia) and osteopenia/osteoporosis, and that vitamin D supplementation decreases the risk for these diseases, provides a relatively easy/accessible and inexpensive model of preventive therapy to decrease the incidence of these diseases. In addition, it is likely that genetic (inherited) factors play a role, but the relationship of these genes to these metabolic abnormalities have not been elucidated. Understanding the role of Vitamin D in health will allow us to translate these findings into therapy.
- Conditions
- Vitamin D Deficiency, Metabolic Syndrome
- Being tested
- RDA Vitamin D3 only, Vitamin D2/3 Repletion only, Vitamin D2/3 Repletion + AEX, Vitamin D2/3 Repletion + RT
- Keywords
- Body Composition, Cardiovascular Risk, Cognitive Function
- Medical subject headings
- Vitamin D Deficiency, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDA Vitamin D3 onlyDietary supplement
Also called ergocalciferol
800 IU of Vitamin D3 daily for 6 months
Vitamin D2/3 Repletion onlyDietary supplement
Also called cholecalciferol, ergocalciferol
Vitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily
Vitamin D2/3 Repletion + AEXOther
Also called cholecalciferol, ergocalciferol
Vitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily plus aerobic exercise training
Vitamin D2/3 Repletion + RTOther
Also called cholecalciferol, ergocalciferol
Vitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily plus resistance training
| Study group | Role | What they receive |
|---|---|---|
| RDA Vitamin D | Active comparator | Not described Receives: Dietary Supplement: RDA Vitamin D3 only |
| Vit D repletion + 6M Supplementation | Experimental | Not described Receives: Dietary Supplement: Vitamin D2/3 Repletion only |
| Vit D repletion + 6M Supplementation +AEX | Experimental | Not described Receives: Other: Vitamin D2/3 Repletion + AEX |
| Vit D repletion + 6M Supplementation +RT | Experimental | Not described Receives: Other: Vitamin D2/3 Repletion + RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose tolerance and insulin sensitivity
Measured: Baseline, 3 months and 6 months
Secondary outcomes (3)
muscle structure, inflammation and metabolic function to cause sarcopenia and frailty
Measured: Baseline, 3 months and 6 months
physical performance, balance and strength to increase strength and balance to reduce fall risk in older people
Measured: Baseline, 3 months and 6 months
cognitive function
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Investigator terminated study due to low enrollment of eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- National Institute on Aging (NIA), Nutrition Obesity Research Center
- Responsible party
- Principal investigator, Andrew P. Goldberg, Baltimore VA Medical Center
- Investigators
- Andrew P Goldberg, M.D., Principal investigator, Baltimore VAMC/GRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145703
- Sponsor's protocol ID
- HP-00040570
- Other IDs
- P30AG028747
- Acronym
- VitD
- Status last verified
- Sep 2014
- First submitted
- 16 Jun 2010
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Supplementation With and With Out Exercise on Metabolic and Physical Consequences of Vitamin D Deficiency in the Elderly
- ClinicalTrials.gov ID
- NCT01145703
- Acronym / sponsor ID
- VitD / HP-00040570
- Conditions
- Vitamin D Deficiency, Metabolic Syndrome
- Keywords
- Body Composition, Cardiovascular Risk, Cognitive Function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator terminated study due to low enrollment of eligible subjects
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Collaborators
- National Institute on Aging (NIA), Nutrition Obesity Research Center
- Study start
- May 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Jun 2010 (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 this study is to examine the effects of Vitamin D supplementation on the reasons (mechanisms) underlying the development of type 2 diabetes, metabolic syndrome (high blood pressure, cholesterol, diabetes, body weight/obesity), muscle weakness and wasting (sarcopenia), and impaired physical function (poor balance and walking) associated with vitamin D deficiency and osteopenia/osteoporosis (bone loss). The investigators obtain vitamin D through our diet and sunlight, and its conversion to active vitamins in the liver and kidneys promotes the intestinal absorption of calcium and regulation of bone growth. Therefore, vitamin D deficiency has been known for years to lead to weakened bones (osteopenia and osteoporosis). However, more recently, studies show vitamin D deficiency is associated with a number of other diseases, including type 2 diabetes, muscle weakness, frailty, and the metabolic syndrome. It has also been associated with cognitive impairment. Diabetes affects multiple organ systems including the heart, kidneys, musculoskeletal and nervous system. The possibility that vitamin D deficiency is linked to the development of type 2 diabetes, metabolic syndrome, muscle weakness and wasting (sarcopenia) and osteopenia/osteoporosis, and that vitamin D supplementation decreases the risk for these diseases, provides a relatively easy/accessible and inexpensive model of preventive therapy to decrease the incidence of these diseases. In addition, it is likely that genetic (inherited) factors play a role, but the relationship of these genes to these metabolic abnormalities have not been elucidated. Understanding the role of Vitamin D in health will allow us to translate these findings into therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RDA Vitamin D | Active comparator | Dietary Supplement: RDA Vitamin D3 only |
| Vit D repletion + 6M Supplementation | Experimental | Dietary Supplement: Vitamin D2/3 Repletion only |
| Vit D repletion + 6M Supplementation +AEX | Experimental | Other: Vitamin D2/3 Repletion + AEX |
| Vit D repletion + 6M Supplementation +RT | Experimental | Other: Vitamin D2/3 Repletion + RT |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 40-85 years of age
- Women must be post menopausal (absence of menses for 12 months or greater)
- 25-hydroxyvitamin D level below 20 ng/ml (50 nmol/L)
- BMI 25-45 kg/m2
- Non smoker ( non smoking for at least 12 months:cigarettes, cigars, pipes)
Key exclusion criteria (18 listed)
- Symptomatic heart disease, CAD, CHF, or uncontrolled hypertension (BP over 180 mm HG) unless medically stabilized
- Currently being treated for active cancer
- Type 1 diabetes; insulin treatment for diabetes, poorly controlled diabetes, HgA1c >10%
- Allergic to lidocaine
- History of seizures or taking anti-seizure or anti convulsion medications
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 |
|---|---|---|
| RDA Vitamin D3 onlyAlso: ergocalciferol800 IU of Vitamin D3 daily for 6 months | Dietary supplement | RDA Vitamin D |
| Vitamin D2/3 Repletion onlyAlso: cholecalciferol, ergocalciferolVitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily | Dietary supplement | Vit D repletion + 6M Supplementation |
| Vitamin D2/3 Repletion + AEXAlso: cholecalciferol, ergocalciferolVitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily plus aerobic exercise training | Other | Vit D repletion + 6M Supplementation +AEX |
| Vitamin D2/3 Repletion + RTAlso: cholecalciferol, ergocalciferolVitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily plus resistance training | Other | Vit D repletion + 6M Supplementation +RT |
Primary outcome
glucose tolerance and insulin sensitivity
Time frame: Baseline, 3 months and 6 months
3 secondary outcomes
muscle structure, inflammation and metabolic function to cause sarcopenia and frailty
Time frame: Baseline, 3 months and 6 months
physical performance, balance and strength to increase strength and balance to reduce fall risk in older people
Time frame: Baseline, 3 months and 6 months
cognitive function
Time frame: Baseline, 3 months and 6 months
Results and safety
The study was stopped early (reason given: Investigator terminated study due to low enrollment of eligible subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
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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.
Andrew P Goldberg, M.D. principal investigator
Baltimore VAMC/GRECC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RDA Vitamin D3 only, Vitamin D2/3 Repletion only and Vitamin D2/3 Repletion + AEX in people with Vitamin D Deficiency and Metabolic Syndrome, run by Baltimore VA Medical Center 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 18 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: stopped early, as of the sponsor's last update on 5 Sep 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 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. 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 was stopped early (reason given: Investigator terminated study due to low enrollment of eligible subjects). Results are not available in the source record.
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?
glucose tolerance and insulin sensitivity (time frame: Baseline, 3 months and 6 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 5 Sep 2014.