Trials / Completed
CompletedNCT01576705
Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 175 (actual)
- Sponsor
- Institut Jerome Lejeune · Academic / Other
- Sex
- All
- Age
- 6 Months – 18 Months
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | thyroid hormone and folinic acid | thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules |
Timeline
- Start date
- 2012-04-02
- Primary completion
- 2017-12-14
- Completion
- 2017-12-14
- First posted
- 2012-04-12
- Last updated
- 2020-05-13
- Results posted
- 2020-05-13
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01576705. Inclusion in this directory is not an endorsement.