NCT02445066

Brief Summary

This pilot study is a 4-month open label trial in 15 older (65-89 yrs) men and women with initial 25(OH)D concentrations of 12-\<18 ng/mL to explore the effect of increasing 25(OH)D concentrations to ≥30 ng/mL through vitamin D3 supplementation on changes in mitochondrial bioenergetics. We will assess the bioenergetic profile of blood cells isolated mitochondria, and muscle fibers as well as the expression of mitochondrial proteins and regulators of mitochondria biogenesis before and after supplementation. All participants will be given vitamin D3 (4,000 IU/d) for 4 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Oct 2014

Typical duration for early_phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

May 11, 2015

Last Update Submit

August 13, 2018

Conditions

Low 25-hydroxyvitamin D Concentrations

Keywords

Vitamin D

Outcome Measures

Primary Outcomes (1)

  • Respirometric profiling

    Respirometry of isolated mitochondria will be performed in order to examine intrinsic mitochondrial function (type1). Respirometry of permeabilized muscle fibers will be performed to assess type 2 alterations in mitochondrial function. Mitochondrial mass and biogenesis will be determined by western blot analysis. Blood based bioenergetic profiling - PBMC's, monocytes, lymphocytes, and platelets will be separated from whole blood and assessed for basal respiration, maximal respiration, ATP linked respiration, spare respiratory capacity, proton leak, and non-mitochondrial respiration.

    4 months

Secondary Outcomes (3)

  • Lower extremity muscle power

    4 months

  • Physical performance

    4 months

  • Grip strength

    4 months

Study Arms (1)

Open label

OTHER

Vitamin D3 - 4,000 IU/day for 4 months

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT
Open label

Eligibility Criteria

Age65 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • SPPB score of 10 or less
  • initial serum 25(OH)D concentration of 12-17.9 ng/mL
  • not dependent on a walker
  • willing to provide informed consent and to adhere to the protocol
  • not involved in another behavioral, exercise, or investigational drug intervention study
  • self-reported physical performance difficulty
  • were screened for the EVIDENCE study within the last 2 months

You may not qualify if:

  • serious or uncontrolled chronic disease
  • evidence of impaired cognitive function (MoCA\<18)
  • taking prescription vitamin D2 or taking \>1000 IU/day of vitamin D3 from all sources; taking an oral corticosteroid; taking hormone replacement therapy
  • inability or contraindications to consume daily vitamin D supplements
  • knee or hip surgery within the last 6 months or planned knee or hip surgery within the next year
  • not willing or eligible to undergo a muscle biopsy (on blood thinners)
  • weight loss of greater than or equal to 5% in the past 3 months
  • BMI \> 40kg/m2
  • eye surgery within the past month or planned within the next month
  • if the PI feels the participant is unlikely to follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Anthony Molina, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 15, 2015

Study Start

October 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

US(1)