Status:
TERMINATED
Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly
Lead Sponsor:
Baltimore VA Medical Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Nutrition Obesity Research Center
Conditions:
Vitamin D Deficiency
Metabolic Syndrome
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief 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, cho...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01145703
Start Date
May 1 2010
End Date
February 1 2013
Last Update
September 5 2014
Active Locations (1)
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1
Baltimore VAMC
Baltimore, Maryland, United States, 21201