We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01145703
First Posted: June 17, 2010
Last Update Posted: September 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Aging (NIA)
Nutrition Obesity Research Center (NORC)
Information provided by (Responsible Party):
Andrew P. Goldberg, Baltimore VA Medical Center
  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
Intervention Model: Factorial Assignment
Masking: None (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 Andrew P. Goldberg, Baltimore VA Medical Center:

Primary Outcome Measures:
  • glucose tolerance and insulin sensitivity [ Time Frame: Baseline, 3 months and 6 months ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145703


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

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 ( U.S. NIH Grant/Contract )
First Submitted: June 16, 2010
First Posted: June 17, 2010
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by Andrew P. Goldberg, 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
Bone Density Conservation Agents