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Vitamin D and Muscle Metabolic Function

Vitamin D Contribution to Muscle Metabolic Function in Aged Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02221596
Enrollment
50
Registered
2014-08-20
Start date
2014-09-30
Completion date
2018-03-01
Last updated
2018-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Vitamin D, 25(OH)D, Aerobic training, Near-infrared spectroscopy, Diffuse correlation spectroscopy, MRS

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.

Interventions

DIETARY_SUPPLEMENTvitamin D

50,000IU/wk of vitamin D3

OTHERaerobic training

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

Sponsors

David Travis Thomas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
blood measureChange from Baseline in vitamin D at 13 weeksvitamin D

Secondary

MeasureTime frameDescription
muscle lipidbaseline and 13 weeks after baselineIntramyocellular lipid and extramyocellular lipid will be assessed using magnetic resonance spectroscopy and fat segmentation.
muscle oxygen consumptionbaseline and 13 weeks after baselineLocal 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026