NCT02346786

Brief Summary

sports accidents and incidents are relatively frequent. We hypothesize that the pursuit of good hydration, including days without training or competition could prevent their occurrence

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_3

Status
unknown

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

January 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

7 months

First QC Date

January 21, 2015

Last Update Submit

February 8, 2015

Conditions

FracturesSprainStress FracturesAchesTendinitis

Keywords

Drinking WaterMineral waterSportsAccident prevention

Outcome Measures

Primary Outcomes (1)

  • number of incidents and accidents in sport practice

    6 months

Secondary Outcomes (3)

  • estimated level of physical activity

    6 month

  • Warm-up time

    6 months

  • weigh

    6 months

Study Arms (2)

Mineral Water

EXPERIMENTAL

mineral water

Dietary Supplement: eau minérale d'Aix-Les-Bains

Tap Water

ACTIVE COMPARATOR

usual water intake

Dietary Supplement: tap water

Interventions

eau minérale d'Aix-Les-BainsDIETARY_SUPPLEMENT

Sodium 0.44 mg Magnésium 2.25 mg Phosphore 0.003 mg Potassium 0.08 mg Calcium 8.23 mg Manganèse 0.0001 mg Fer 0.001 mg Cuivre 0.0005 mg Zinc 0.0005 mg Sélénium 1 µg Iode 0 µg

Mineral Water
tap waterDIETARY_SUPPLEMENT
Tap Water

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Sports practitioners aged 12 to 80 years;
  • Enrolled in one of two clubs participating in the study

You may not qualify if:

  • Pregnant or breastfeeding.
  • Major Licensee protected by law or deprived of liberty by administrative and judicial decisions;
  • Licensee with an contra-indication for drinking water of Aix (anuric renal failure for example)
  • Having dismissed contra-indication for sport practice (unlikely event, regulation of clubs requiring a medical certificate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fractures, BoneSprains and StrainsFractures, StressPainTendinopathy

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesTendon Injuries

Central Study Contacts

Romain J FORESTIER, MD

CONTACT

0479351487romain.forestier@wanadoo.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

January 21, 2015

First Posted

January 27, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

May 1, 2016

Last Updated

February 10, 2015

Record last verified: 2015-02