Vitamin D and Muscle Metabolic Function

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: vitamin D; Other: aerobic training

• Registration Number: NCT02221596
• Lead Sponsor: David Travis Thomas

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.

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 Timeline

• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-20
• Study Start: 2014-09
• Primary Completion: 2018-02-28
• Status Verified: 2018-03
• Study Completion: 2018-03-01
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
vitamin D + aerobic training	vitamin D	vitamin D capsules every weekday (10,000IU/day) and exercise
placebo + aerobic training	aerobic training	placebo capsule every weekday and exercise
vitamin D + aerobic training	aerobic training	vitamin D capsules every weekday (10,000IU/day) and exercise
vitamin D + no aerobic training	vitamin D	vitamin D capsules every weekday (10,000IU/day) and no exercise

Primary Outcome Measures

Name	Time	Method
blood measure	Change from Baseline in vitamin D at 13 weeks	vitamin D

Secondary Outcome Measures

Name	Time	Method
muscle lipid	baseline and 13 weeks after baseline	Intramyocellular lipid and extramyocellular lipid will be assessed using magnetic resonance spectroscopy and fat segmentation.
muscle oxygen consumption	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)

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States