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Completed

NCT Number: NCT02221596

Vitamin D and Muscle Metabolic Function

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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

50,000IU/wk of vitamin D3

Aerobic training

Other

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

Primary outcomes

  1. blood measure

    Time frame: Change from Baseline in vitamin D at 13 weeks

    vitamin D

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

David Travis Thomas

Other

Registry information

Official study title

Vitamin D Contribution to Muscle Metabolic Function in Aged Adults

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 20, 2014
Registry last updated
Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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