Vitamin D and Muscle Metabolic Function

NCT ID: NCT02221596

Last Updated: 2018-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-03-01

Brief Summary

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The purpose of this study is to identify the magnitude of muscle lipid redistribution and muscle oxygen use in individuals 60 years old or older following combined treatment of vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic training alone, or no treatment.

Detailed Description

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The investigators plan to recruit approximately 56 aged individuals with vitamin D insufficiency for a 13 week trial. All subjects will be 60 years of age or older. Participants will be randomized to one of four groups: vitamin D (50,000IU/wk) + aerobic training (7 days during the 13th week); vitamin D (50,000IU/wk) + normal daily activity during the 13th week; placebo + aerobic training (7 days during the 13th week); or placebo + normal daily activity during the 13th week.

Following screening and informed consent process a physical activity questionnaire will be administered. A blood draw will then be conducted at baseline, midpoint and endpoint. Collected blood for the purposes of this study will assess vitamin D status (25(OH)D), parathyroid hormone, ionized calcium, insulin, and a comprehensive metabolic panel. At baseline and endpoint muscle lipid will be assessed using Magnetic Resonance Spectroscopy and muscle oxygen consumption will be determined using a novel hybrid diffuse optical instrument consisting of a near-infrared spectroscopy and a diffuse correlation spectroscopy. In addition, at each study time point 3 dietary recalls will be completed and physical activity will be measured using an accelerometer.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vitamin D + aerobic training

vitamin D capsules every weekday (10,000IU/day) and exercise

Group Type EXPERIMENTAL

vitamin D

Intervention Type DIETARY_SUPPLEMENT

50,000IU/wk of vitamin D3

aerobic training

Intervention Type OTHER

7 days of treadmill training during the 13th week of study

vitamin D + no aerobic training

vitamin D capsules every weekday (10,000IU/day) and no exercise

Group Type ACTIVE_COMPARATOR

vitamin D

Intervention Type DIETARY_SUPPLEMENT

50,000IU/wk of vitamin D3

placebo + aerobic training

placebo capsule every weekday and exercise

Group Type ACTIVE_COMPARATOR

aerobic training

Intervention Type OTHER

7 days of treadmill training during the 13th week of study

placebo + no aerobic training

placebo capsule every weekday and no exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vitamin D

50,000IU/wk of vitamin D3

Intervention Type DIETARY_SUPPLEMENT

aerobic training

7 days of treadmill training during the 13th week of study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age: 60 and older
* BMI: 18.5-29
* Communicates fluently in English

Exclusion Criteria

* Metal implant not suitable for MRI
* Any form of hormone replacement therapy
* Engage in more than 1 hr/week of vigorous activity
* Participated in a high-intensity resistance or aerobic training program in the last 3 months
* Lower extremity injury or surgery in the past 3 months
* Foot sores or bone conditions severely limiting ability to move or perform exercise or joint pain made worse by mild exercise
* Diabetes, inflammatory bowel disease, renal disease or uncontrolled hypertension.
* Currently have or had a history of cardiovascular or pulmonary disease that would preclude the involvement in the performance of exercise
* History of myopathy (including congenital myopathies)
* History of neurological conditions related to spinal derangement, disk disease, peripheral neuropathies, tremor and rigidity
* Past medical history of hyperparathyroidism, kidney stones or rhabdomyolysis
* Currently receiving treatment for vitamin D deficiency
* Vitamin D level \>30ng/mL
* Currently smoking
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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David Travis Thomas

OTHER

Sponsor Role lead

Responsible Party

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David Travis Thomas

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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D. Travis Thomas, Ph.D., RD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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1R21AG046762-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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