Clinical trial NCT02221596: Vitamin D and Muscle Metabolic Function
Official title: Vitamin D Contribution to Muscle Metabolic Function in Aged Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Vitamin D
25(OH)D
Aerobic training
Near-infrared spectroscopy
Diffuse correlation spectroscopy
MRS
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: blood measure
timeFrame: Change from Baseline in vitamin D at 13 weeks
Secondary outcomes:
measure: muscle lipid
timeFrame: baseline and 13 weeks after baseline
measure: muscle oxygen consumption
timeFrame: baseline and 13 weeks after baseline
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: D. Travis Thomas, Ph.D., RD
role: PRINCIPAL_INVESTIGATOR
References: