Impact on Functional Status in Older Adults Treated With L-Carnitine

NCT03180424 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-06-08

No results posted yet for this study

Summary

This study evaluates the impact of the treatment with L-Carnitine on the function of adults over 65 years, in conjunction with regular exercise. Simple randomization will be performed, distributing patients in 3 treatment groups, with L-Carnitine or Placebo, and with physical exercise at home or supervised.

Conditions

  • Carnitine; Muscle
  • Functional Status
  • Old Age; Debility

Interventions

DRUG

L Carnitine

L Carnitine liquid, single daily dose of 2g orally.

BEHAVIORAL

Supervised exercise

Modified Otago exercise programme, 2 times a week with a duration of 45 minutes, to be supervised by a previously qualified and trained instructor. Follow up of the established plan includes an adequate monitoring, evaluating the evolution and the possible adverse effects that may appear.

DRUG

Placebos

Liquid substance, similar to the one containing L carnitine, in the same presentation

BEHAVIORAL

Exercise at home

A schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision

Sponsors & Collaborators

  • University of the Republic, Uruguay

    collaborator OTHER
  • Hospital de Clínicas Dr. Manuel Quintela

    lead OTHER

Principal Investigators

  • Aldo Sgaravatti, MD · HospítalCDMQ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2017-08-31
Completion
2017-09-30
FDA Drug
Yes

Countries

  • Uruguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03180424 on ClinicalTrials.gov