Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Endocrine, Gastrointestinal |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | May 2010 |
| End Date: | May 2015 |
| Contact: | Lynda Robey, M.S. |
| Email: | lynda.robey@va.gov |
| Phone: | 410-605-7000 |
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.
Inclusion Criteria:
- 50-85 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 Criteria:
- 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
- Abnormal renal function (BUN above 40 mg/dl, Cr above 1.3 mg/dl, CrCl<60mg/dl)
- Hypercalcemia (Ca>10.2mg/dl)
- Anemia HCT below 35 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.
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