NCT02275429

Brief Summary

Acute consequences of ultramarathon running are still unknown as very little research has been done on the matter. The investigators will assess the consequences on the metabolism of runners in the ultramarathon Madmen's Diagonal on Reunion Island. Data from the literature suggest that runners undergo loss of zinc, copper, iron, magnesium not unlike the loss of metabolites in systemic inflammatory response syndrome. The purpose of this study is to assess the metabolic disorders (selenium, zinc, vitamins B9 and B12) in ultramarathon runners, during and up to 28 days after the Madmen's Diagonal which takes place on Reunion Island every year in October.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

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
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

1 month

First QC Date

October 15, 2014

Last Update Submit

July 28, 2015

Conditions

Metabolic Diseases

Keywords

Metabolic DiseasesAthletesRunningSeleniumZincIron Metabolism DisordersWater-Electrolyte ImbalanceHyperkalemiaHypernatremiaSelenium levels before and after the raceLevels of other electrolytes and markers

Outcome Measures

Primary Outcomes (1)

  • Assess the selenium levels

    Blood wil be analyzed prior to the start of the race, upon completion of the race (anywhere between 27 and 67 hours after the start of the race), and upon days 7 and 28. Blood will be drawn in the same medical laboratory at the Reunion Island University Hospital site of Saint Denis.

    28 days

Secondary Outcomes (7)

  • - Assess Ions and trace metals (Sodium, Potassium, Chloride, Zinc)

    28 days

  • - Assess Renal function tests (creatinine, blood urea nitrogen)

    28 days

  • - Assess liver function (total protein, cardiac markers (myoglobin, CPK-MB)

    28 days

  • - Assess iron and ferritin

    28 days

  • - Assess blood disorder (vitamin B12, folic acid or vitamin B9)

    28 days

  • +2 more secondary outcomes

Study Arms (1)

Runners

OTHER

Each year, about 1,200 runners residing on Reunion Island take the start of the Madmen's Diagonal ultramarathon. Among those, 500 runners will be selected at random and will receive a letter informing them of the study and requesting their participation. Those who accept are to contact the study team. Among those volunteers, 100 runners will be selected randomly and included in the study. They will undergo a blood test the day before the race starts (day 0, when they retrieve their race number), upon completion of the race, and upon days 7 and 28.

Procedure: Blood test

Interventions

Blood testPROCEDURE

blood will be drawn the day before the race (day 0), upon completion of the race (between 27 and 67 hours after departure), and on days 7 and 28

Runners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ultramarathon runner in the Madmen's Diagonal on Reunion Island (October 2014 )
  • Aged 18 years or older
  • Lives on Reunion Island
  • Gave informed consent
  • Medical certificate allowing the participation in an ultramarathon

You may not qualify if:

  • Aged less than 18 years Ultramarathon runner in the Bourbon Trail or Mascarenes races (which take place at the same time as the Madmen's Diagonal)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reunion Island University Hospital

Saint-Denis, Reunion Island, 97410, France

Location

MeSH Terms

Conditions

Metabolic DiseasesIron Metabolism DisordersWater-Electrolyte ImbalanceHyperkalemiaHypernatremia

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Jérôme SUDRIAL, MD

    CHU Réunion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2014

First Posted

October 27, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

FR(1)