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

This study is ongoing, but not recruiting participants.
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: February 21, 2013
Last verified: February 2013

June 16, 2010
February 21, 2013
May 2010
May 2015   (final data collection date for primary outcome measure)
glucose tolerance and insulin sensitivity [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
glucose tolerance and insulin sensitivity [ Time Frame: Baseline, 3 months and 9 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01145703 on ClinicalTrials.gov Archive Site
  • 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 ]
  • muscle structure, inflammation and metabolic function to cause sarcopenia and frailty [ Time Frame: Baseline, 3 months and 9 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 9 months ] [ Designated as safety issue: No ]
  • cognitive function [ Time Frame: Baseline, 3 months and 9 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Vitamin D Deficiency
  • Metabolic Syndrome
  • Dietary Supplement: RDA Vitamin D3 only
    800 IU of Vitamin D3 daily for 6 months
    Other Name: ergocalciferol
  • 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
  • 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
  • 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
  • Active Comparator: RDA Vitamin D
    Intervention: Dietary Supplement: RDA Vitamin D3 only
  • Experimental: Vit D repletion + 6M Supplementation
    Intervention: Dietary Supplement: Vitamin D2/3 Repletion only
  • Experimental: Vit D repletion + 6M Supplementation +AEX
    Intervention: Other: Vitamin D2/3 Repletion + AEX
  • Experimental: Vit D repletion + 6M Supplementation +RT
    Intervention: Other: Vitamin D2/3 Repletion + RT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
May 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
40 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01145703
HP-00040570, P30AG028747
Yes
Andrew P. Goldberg, Baltimore VA Medical Center
Baltimore VA Medical Center
  • National Institute on Aging (NIA)
  • Nutrition Obesity Research Center (NORC)
Principal Investigator: Andrew P Goldberg, M.D. Baltimore VAMC/GRECC
Baltimore VA Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP