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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01576705 |
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Date of registration:
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11/04/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children
ACTHYF |
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Scientific title:
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Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children |
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Date of first enrolment:
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April 2, 2012 |
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Target sample size:
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175 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01576705 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Clotilde MIRCHER, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Jerome Lejeune, Paris, France |
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Name:
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Franck STURTZ, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Biochemistry and Molecular Genetics, Limoges University, Limoges, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation
trisomy 21
- patient having undergone a cardiac ultrasound not demonstrating any severe heart
disease
- patient aged 6 to 18 months at inclusion
Exclusion Criteria:
- congenital hypothyroidism
- hypothyroidism demonstrated by laboratory tests (TSH > 7mUI/l)
- presenting or having presented hyperthyroidism
- presenting or having presented leukaemia
- presenting or having presented West syndrome or any other form of epilepsy or unstable
neurological disease
- presenting or having presented signs of central nervous system distress: stroke,
postoperative hypoxia, meningitis)
- presenting severe heart disease on cardiac ultrasound, with haemodynamic effects
- presenting non-controlled cardiac arrhythmia
- Apgar < 7 to 5 min at birth
- Gestational age < 231 days (33 gestation weeks)
Age minimum:
6 Months
Age maximum:
18 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Down Syndrome
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Intervention(s)
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Drug: thyroid hormone and folinic acid
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Primary Outcome(s)
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GMDS (Griffiths Mental Development Scale)
[Time Frame: 12 months]
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Secondary Outcome(s)
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BL (Brunet Lezine Revised Scale)
[Time Frame: 12 months]
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Secondary ID(s)
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IJL-AFHT-TH10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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