At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 175 enrolled
Drug / intervention
thyroid hormone and folinic aciddrug
Likely dose
thyroid hormone and folinic acid 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children
In Brief
A Phase 3 clinical trial evaluating thyroid hormone and folinic acid for Down Syndrome. Completed, enrolled 175 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDown Syndrome
CountriesFrance
CollaboratorsHôpital Cochin, Central Hospital, Nancy, France
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedApr 2012
Primary CompletionDec 2017
TodayJul 2026
First PostedApr 12, 2012
Enrollment StartApr 2, 2012
Primary CompletionDec 14, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.2 years ago
Interventions
thyroid hormone and folinic aciddrug
thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules