NCT01666587

Brief Summary

The purposes of this study are two-fold. The first purpose is to determine the effect of taking vitamins on the recovery of an artery (blood vessel) following an induced temporary injury. The second purpose is to determine whether a specific vasodilator is less abundant after the injury and whether this contributes to increased constriction or after the injury. Finally, does vitamin consumption have an effect on the recovery from the injury if one of the substances in the blood that causes vessels to enlarge (dilate) is stopped?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

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

Study Start

First participant enrolled

August 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

August 9, 2012

Last Update Submit

May 10, 2017

Conditions

Ischemic Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

  • Change in flow mediated dilation

    Flow mediated dilation is a measure of vascular function and is measured as the outcome before and after an injury to the inner lining of the artery.

    Change from baseline at 15 minutes after ischemia-reperfusion injury

Secondary Outcomes (1)

  • Change in low flow mediated constriction

    Change from baseline at 15 minutes after ischemia-reperfusion injury

Study Arms (4)

control

NO INTERVENTION

Control trial to determine the impact of the ischemic injury on vascular function without intervention

Antioxidant load

EXPERIMENTAL

Trial to determine the impact of an antioxidant load before the ischemic injury on vascular function recovery

Dietary Supplement: Antioxidant

Prostaglandin inhibition

EXPERIMENTAL

Trial to determine the impact of a non-selective prostaglandin inhibitor before the ischemic injury on vascular function recovery

Drug: Prostaglandin inhibitor (Ibuprophen)

Combined

EXPERIMENTAL

Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery

Dietary Supplement: AntioxidantDrug: Prostaglandin inhibitor (Ibuprophen)

Interventions

AntioxidantDIETARY_SUPPLEMENT
Antioxidant loadCombined
Prostaglandin inhibitor (Ibuprophen)DRUG
Also known as: ibuprofen
CombinedProstaglandin inhibition

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males
  • Healthy females

You may not qualify if:

  • Smokers
  • Cardiovascular disease
  • Peripheral vascular disease
  • Neurological deficits
  • Diabetes Type I or II
  • Pregnant women
  • Adverse reactions to Ibuprofen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Essex

Colchester, Essex, CO4 3SQ, United Kingdom

Location

MeSH Terms

Interventions

AntioxidantsProstaglandin AntagonistsIbuprofen

Intervention Hierarchy (Ancestors)

Biological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of ChemicalsHormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Mark Rakobowchuk, PhD

    Thompson Rivers University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 16, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

August 1, 2013

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations

GB(1)