Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly

NCT01145703 | Terminated DMC

• 2 other identifiers: HP-00040570P30AG028747
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin D Deficiency; Metabolic Syndrome

Keywords

Body Composition; Cardiovascular Risk; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• glucose tolerance and insulin sensitivity

  Baseline, 3 months and 6 months

Secondary Outcomes (3)

• muscle structure, inflammation and metabolic function to cause sarcopenia and frailty

  Baseline, 3 months and 6 months

• physical performance, balance and strength to increase strength and balance to reduce fall risk in older people

  Baseline, 3 months and 6 months

• cognitive function

  Baseline, 3 months and 6 months

Study Arms (4)

RDA Vitamin D

ACTIVE COMPARATOR

Dietary Supplement: RDA Vitamin D3 only

Vit D repletion + 6M Supplementation

EXPERIMENTAL

Dietary Supplement: Vitamin D2/3 Repletion only

Vit D repletion + 6M Supplementation +AEX

EXPERIMENTAL

Other: Vitamin D2/3 Repletion + AEX

Vit D repletion + 6M Supplementation +RT

EXPERIMENTAL

Other: Vitamin D2/3 Repletion + RT

Interventions

RDA Vitamin D3 only DIETARY_SUPPLEMENT

800 IU of Vitamin D3 daily for 6 months

Also known as: ergocalciferol

RDA Vitamin D

Vitamin D2/3 Repletion only DIETARY_SUPPLEMENT

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

Also known as: cholecalciferol, ergocalciferol

Vit D repletion + 6M Supplementation

Vitamin D2/3 Repletion + AEX OTHER

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

Also known as: cholecalciferol, ergocalciferol

Vit D repletion + 6M Supplementation +AEX

Vitamin D2/3 Repletion + RT OTHER

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

Also known as: cholecalciferol, ergocalciferol

Vit D repletion + 6M Supplementation +RT

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Women must be post menopausal (absence of menses for 12 months or greater)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baltimore VA Medical Center: lead
• National Institute on Aging (NIA): collaborator
• Nutrition Obesity Research Center: collaborator

Study Sites (1)

Baltimore VAMC

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Metabolic Syndrome

Interventions

Ergocalciferols; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Andrew P Goldberg, M.D.

  Baltimore VAMC/GRECC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GRECC Director, Professor of Medicine

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 17, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 5, 2014

Record last verified: 2014-09

Locations

US (1)