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Vitamin D and Muscle Metabolic Function

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ClinicalTrials.gov Identifier: NCT02221596
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
David Travis Thomas, University of Kentucky

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: vitamin D Other: aerobic training Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Vitamin D Contribution to Muscle Metabolic Function in Aged Adults
Study Start Date : September 2014
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: vitamin D + aerobic training
vitamin D capsules every weekday (10,000IU/day) and exercise
Dietary Supplement: vitamin D
50,000IU/wk of vitamin D3

Other: aerobic training
7 days of treadmill training during the 13th week of study

Active Comparator: vitamin D + no aerobic training
vitamin D capsules every weekday (10,000IU/day) and no exercise
Dietary Supplement: vitamin D
50,000IU/wk of vitamin D3

Active Comparator: placebo + aerobic training
placebo capsule every weekday and exercise
Other: aerobic training
7 days of treadmill training during the 13th week of study

No Intervention: placebo + no aerobic training
placebo capsule every weekday and no exercise



Primary Outcome Measures :
  1. blood measure [ Time Frame: Change from Baseline in vitamin D at 13 weeks ]
    vitamin D


Secondary Outcome Measures :
  1. muscle lipid [ Time Frame: baseline and 13 weeks after baseline ]
    Intramyocellular lipid and extramyocellular lipid will be assessed using magnetic resonance spectroscopy and fat segmentation.

  2. muscle oxygen consumption [ Time Frame: baseline and 13 weeks after baseline ]
    Local muscle tissue oxidative capacity will be measured using a novel hybrid diffuse optical instrument consisting of a near-infrared spectroscopy (NIRS) and a diffuse correlation spectroscopy (DCS)



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02221596


Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
David Travis Thomas
Investigators
Principal Investigator: D. Travis Thomas, Ph.D., RD University of Kentucky

Responsible Party: David Travis Thomas, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02221596     History of Changes
Other Study ID Numbers: 1R21AG046762-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Keywords provided by David Travis Thomas, University of Kentucky:
Vitamin D
25(OH)D
Aerobic training
Near-infrared spectroscopy
Diffuse correlation spectroscopy
MRS

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents