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

Primary Purpose

Vitamin D Deficiency, Metabolic Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RDA Vitamin D3 only
Vitamin D2/3 Repletion only
Vitamin D2/3 Repletion + AEX
Vitamin D2/3 Repletion + RT
Sponsored by
Baltimore VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Body Composition, Cardiovascular Risk, Cognitive Function

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Baltimore VAMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

RDA Vitamin D

Vit D repletion + 6M Supplementation

Vit D repletion + 6M Supplementation +AEX

Vit D repletion + 6M Supplementation +RT

Arm Description

Outcomes

Primary Outcome Measures

glucose tolerance and insulin sensitivity

Secondary Outcome Measures

muscle structure, inflammation and metabolic function to cause sarcopenia and frailty
physical performance, balance and strength to increase strength and balance to reduce fall risk in older people
cognitive function

Full Information

First Posted
June 16, 2010
Last Updated
September 4, 2014
Sponsor
Baltimore VA Medical Center
Collaborators
National Institute on Aging (NIA), Nutrition Obesity Research Center (NORC)
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1. Study Identification

Unique Protocol Identification Number
NCT01145703
Brief Title
Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Investigator terminated study due to low enrollment of eligible subjects
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baltimore VA Medical Center
Collaborators
National Institute on Aging (NIA), Nutrition Obesity Research Center (NORC)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Metabolic Syndrome
Keywords
Body Composition, Cardiovascular Risk, Cognitive Function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RDA Vitamin D
Arm Type
Active Comparator
Arm Title
Vit D repletion + 6M Supplementation
Arm Type
Experimental
Arm Title
Vit D repletion + 6M Supplementation +AEX
Arm Type
Experimental
Arm Title
Vit D repletion + 6M Supplementation +RT
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
RDA Vitamin D3 only
Other Intervention Name(s)
ergocalciferol
Intervention Description
800 IU of Vitamin D3 daily for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D2/3 Repletion only
Other Intervention Name(s)
cholecalciferol, ergocalciferol
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Vitamin D2/3 Repletion + AEX
Other Intervention Name(s)
cholecalciferol, ergocalciferol
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Vitamin D2/3 Repletion + RT
Other Intervention Name(s)
cholecalciferol, ergocalciferol
Intervention Description
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
Primary Outcome Measure Information:
Title
glucose tolerance and insulin sensitivity
Time Frame
Baseline, 3 months and 6 months
Secondary Outcome Measure Information:
Title
muscle structure, inflammation and metabolic function to cause sarcopenia and frailty
Time Frame
Baseline, 3 months and 6 months
Title
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
Title
cognitive function
Time Frame
Baseline, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew P Goldberg, M.D.
Organizational Affiliation
Baltimore VAMC/GRECC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VAMC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly

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