Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly

Metabolic Syndrome Clinical Trial

— VitD  

Official title:

Effects of Vitamin D Supplementation With and With Out Exercise on Metabolic and Physical Consequences of Vitamin D Deficiency in the Elderly

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01145703
• Other study ID #: HP-00040570
• Secondary ID: P30AG028747
• Status: Terminated
• Phase: N/A
• First received: June 16, 2010
• Last updated: September 4, 2014
• Start date: May 2010
• Est. completion date: February 2013

Study information

• Verified date: September 2014
• Source: Baltimore VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 (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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• RDA Vitamin D3 only
800 IU of Vitamin D3 daily for 6 months
• Vitamin D2/3 Repletion only
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

Other:
• Vitamin D2/3 Repletion + AEX
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 + RT
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

Locations

Country	Name	City	State
United States	Baltimore VAMC	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Baltimore VA Medical Center	National Institute on Aging (NIA), Nutrition Obesity Research Center (NORC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose tolerance and insulin sensitivity		Baseline, 3 months and 6 months	No
Secondary	muscle structure, inflammation and metabolic function to cause sarcopenia and frailty		Baseline, 3 months and 6 months	No
Secondary	physical performance, balance and strength to increase strength and balance to reduce fall risk in older people		Baseline, 3 months and 6 months	No
Secondary	cognitive function		Baseline, 3 months and 6 months	No