NCT02221596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

3.5 years

First QC Date

August 14, 2014

Last Update Submit

March 14, 2018

Conditions

Healthy

Keywords

Vitamin D25(OH)DAerobic trainingNear-infrared spectroscopyDiffuse correlation spectroscopyMRS

Outcome Measures

Primary Outcomes (1)

  • blood measure

    vitamin D

    Change from Baseline in vitamin D at 13 weeks

Secondary Outcomes (2)

  • muscle lipid

    baseline and 13 weeks after baseline

  • muscle oxygen consumption

    baseline and 13 weeks after baseline

Study Arms (4)

vitamin D + aerobic training

EXPERIMENTAL

vitamin D capsules every weekday (10,000IU/day) and exercise

Dietary Supplement: vitamin DOther: aerobic training

vitamin D + no aerobic training

ACTIVE COMPARATOR

vitamin D capsules every weekday (10,000IU/day) and no exercise

Dietary Supplement: vitamin D

placebo + aerobic training

ACTIVE COMPARATOR

placebo capsule every weekday and exercise

Other: aerobic training

placebo + no aerobic training

NO INTERVENTION

placebo capsule every weekday and no exercise

Interventions

vitamin DDIETARY_SUPPLEMENT

50,000IU/wk of vitamin D3

vitamin D + aerobic trainingvitamin D + no aerobic training
aerobic trainingOTHER

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

placebo + aerobic trainingvitamin D + aerobic training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 60 and older
  • BMI: 18.5-29
  • Communicates fluently in English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • D. Travis Thomas, Ph.D., RD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 20, 2014

Study Start

September 1, 2014

Primary Completion

February 28, 2018

Study Completion

March 1, 2018

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

US(1)