Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly (VitD)

This study has been terminated.
(Investigator terminated study due to low enrollment of eligible subjects)
Sponsor:
Collaborators:
Nutrition Obesity Research Center (NORC)
Information provided by (Responsible Party):
Andrew P. Goldberg, Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT01145703
First received: June 16, 2010
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Metabolic Syndrome
Dietary Supplement: RDA Vitamin D3 only
Dietary Supplement: Vitamin D2/3 Repletion only
Other: Vitamin D2/3 Repletion + AEX
Other: Vitamin D2/3 Repletion + RT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Vitamin D Supplementation With and With Out Exercise on Metabolic and Physical Consequences of Vitamin D Deficiency in the Elderly

Resource links provided by NLM:


Further study details as provided by Baltimore VA Medical Center:

Primary Outcome Measures:
  • glucose tolerance and insulin sensitivity [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • muscle structure, inflammation and metabolic function to cause sarcopenia and frailty [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • cognitive function [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RDA Vitamin D Dietary Supplement: RDA Vitamin D3 only
800 IU of Vitamin D3 daily for 6 months
Other Name: ergocalciferol
Experimental: Vit D repletion + 6M Supplementation Dietary Supplement: 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 Names:
  • cholecalciferol
  • ergocalciferol
Experimental: Vit D repletion + 6M Supplementation +AEX 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
Other Names:
  • cholecalciferol
  • ergocalciferol
Experimental: Vit D repletion + 6M Supplementation +RT Other: 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
Other Names:
  • cholecalciferol
  • ergocalciferol

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145703

Locations
United States, Maryland
Baltimore VAMC
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Baltimore VA Medical Center
Nutrition Obesity Research Center (NORC)
Investigators
Principal Investigator: Andrew P Goldberg, M.D. Baltimore VAMC/GRECC
  More Information

Additional Information:
No publications provided

Responsible Party: Andrew P. Goldberg, GRECC Director, Professor of Medicine, Baltimore VA Medical Center
ClinicalTrials.gov Identifier: NCT01145703     History of Changes
Other Study ID Numbers: HP-00040570, P30AG028747
Study First Received: June 16, 2010
Last Updated: September 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Baltimore VA Medical Center:
Body Composition
Cardiovascular Risk
Cognitive Function

Additional relevant MeSH terms:
Metabolic Syndrome X
Vitamin D Deficiency
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 22, 2014