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Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children

NCT01576705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2020-05-13

Study results available
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Summary

Evaluation of the following in very young children with Down syndrome:

* the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically and by ultrasensitive thyreostimulating hormone (TSH) assay),
* the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,
* any interaction between these two treatments.

Conditions

  • Down Syndrome

Interventions

DRUG

thyroid hormone and folinic acid

thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules

Sponsors & Collaborators

  • Hôpital Cochin

    collaborator OTHER

  • Central Hospital, Nancy, France

    collaborator OTHER

  • Institut Jerome Lejeune

    lead OTHER

Principal Investigators

  • Clotilde MIRCHER, MD · Institut Jerome Lejeune, Paris, France

  • Franck STURTZ, MD, PhD · Department of Biochemistry and Molecular Genetics, Limoges University, Limoges, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-02
Primary Completion
2017-12-14
Completion
2017-12-14

Countries

  • France

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 NCT01576705 on ClinicalTrials.gov