NCT01356199

Brief Summary

The purpose of this study is to determine whether the nutritional supplement ARTRONAT improves the quality of life of patients with osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

May 17, 2011

Last Update Submit

March 17, 2014

Conditions

Osteoarthritis

Keywords

GonalgiaQuality of LifeDietary supplementNutrition

Outcome Measures

Primary Outcomes (1)

  • Reduction of gonalgia

    measure with the WOMAC.

    T8 months

Secondary Outcomes (1)

  • Evaluation of the satisfactory relief of symptoms of osteoarthritis at each visit after the beginning of supplementation, assessed by the patients.

    T2, T4, T6, T8 months

Study Arms (2)

ARTRONAT

EXPERIMENTAL
Dietary Supplement: ARTRONAT

PLACEBO

PLACEBO COMPARATOR
Dietary Supplement: PLACEBO

Interventions

ARTRONATDIETARY_SUPPLEMENT

Dietary supplement containing Glucosamine, Chondroïtine and manganese. 6 per day for 8 months.

ARTRONAT
PLACEBODIETARY_SUPPLEMENT

PLACEBO. 6 per day for 8 months.

PLACEBO

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 40-75 years
  • BMI 18.5-30
  • osteoarthritis type II or III

You may not qualify if:

  • osteoarthritis type I or IV
  • allergy to one of the component of the supplement
  • blood pressure \> 14/8
  • history of knee surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Rééducation et Réadaptation Fonctionnelles de Trestel , Centre Hospitalier Pierre-Le-Damany Lannion

Treviou Treguignec, 22660, France

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Maurice Cloarec, MD

    Association Nationale de Prevention Medicale

    STUDY CHAIR

  • Dominique Baron, MD

    Hospital Center of Lanion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 19, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2013

Study Completion

December 1, 2013

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

FR(1)