Vitamin D and Muscle Metabolic Function

Vitamin D Contribution to Muscle Metabolic Function in Aged Adults

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: vitamin D; Other: aerobic training

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
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood measure	vitamin D	Change from Baseline in vitamin D at 13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle lipid	Intramyocellular lipid and extramyocellular lipid will be assessed using magnetic resonance spectroscopy and fat segmentation.	baseline and 13 weeks after baseline
muscle oxygen consumption	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)	baseline and 13 weeks after baseline

Collaborators and Investigators

• Sponsor: David Travis Thomas
• Investigators: Principal Investigator: D. Travis Thomas, Ph.D., RD, University of Kentucky

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: August 18, 2014
• First Posted (Estimate): August 20, 2014

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Vitamin D; Aerobic training; MRS; Near-infrared spectroscopy; 25(OH)D; Diffuse correlation spectroscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 1R21AG046762-01A1 (U.S. NIH Grant/Contract)