NCT02519764

Brief Summary

The main objective of this study is to evaluate the impact of a hydration protocol "at thirst" compared to other "not at thirst" hydration protocols on the changes in serum sodium in runners of the Ultra Trail Mont-Blanc (UTMB) in 2015.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2015

Completed
Last Updated

November 19, 2025

Status Verified

August 1, 2015

Enrollment Period

29 days

First QC Date

August 7, 2015

Last Update Submit

November 17, 2025

Conditions

AthletesHealthy

Keywords

volunteer runners who are participating in the 2015 Mont Blanc Ultra Trailhydration protocolnatremiaVolunteers

Outcome Measures

Primary Outcomes (2)

  • Natremia (mmol/L)

    Baseline

  • Natremia (mmol/L)

    at finish, Days 0 to 2

Secondary Outcomes (64)

  • Weight (kg)

    Baseline

  • Weight (kg)

    at finish, Days 0 to 2

  • What year did you first start running regularly?

    Baseline

  • What year did you first start running ultra-trail races?

    Baseline

  • How many 100 miles or Ultra-trails races have you completed?

    Baseline

  • +59 more secondary outcomes

Study Arms (2)

Hydration when thirsty

EXPERIMENTAL

Volunteers in this arm habitually follow a hydration protocol that advises hydration when thirst is felt.

Other: Hydration when thirsty.

Not hydration when thirsty

EXPERIMENTAL

Volunteers in this arm habitually follow any other kind of hydration protocol, i.e. not a "hydration when thirsty" protocol.

Other: Not hydration when thirsty

Interventions

Hydration when thirsty.OTHER

Volunteers in this arm habitually follow a hydration protocol that advises hydration when thirst is felt.

Hydration when thirsty
Not hydration when thirstyOTHER

Volunteers in this arm habitually follow any other kind of hydration protocol, i.e. not a "hydration when thirsty" protocol.

Not hydration when thirsty

Eligibility Criteria

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

You may qualify if:

  • The subject must have given his/her informed and signed consent
  • The subject must be insured or beneficiary of a health insurance plan
  • The subject is participating in the 2015 Mont-Blanc Ultra Trail and has no contra-indication for ultra-trail activities

You may not qualify if:

  • The subject is participating in another study
  • The subject is under judicial protection, under tutorship or curatorship
  • The subject refuses to sign the consent
  • It is impossible to correctly inform the subject
  • The subject is pregnant or breastfeeding
  • The subject will be excluded from the study in case of early drop out (before 15 km of trail).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Nice - Hôpital St-Roch

Nice, 06001, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

  • Mouzat K, Raoul C, Polge A, Kantar J, Camu W, Lumbroso S. Liver X receptors: from cholesterol regulation to neuroprotection-a new barrier against neurodegeneration in amyotrophic lateral sclerosis? Cell Mol Life Sci. 2016 Oct;73(20):3801-8. doi: 10.1007/s00018-016-2330-y. Epub 2016 Aug 10.

    PMID: 27510420RESULT

Study Officials

  • Olivier Marès, MD

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2015

First Posted

August 11, 2015

Study Start

August 1, 2015

Primary Completion

August 30, 2015

Study Completion

August 30, 2015

Last Updated

November 19, 2025

Record last verified: 2015-08

Locations

FR(2)