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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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ClinicalTrials.gov Identifier: NCT01576705
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : March 26, 2019
Sponsor:
Collaborators:
Hôpital Cochin
Central Hospital, Nancy, France
Information provided by (Responsible Party):
Institut Jerome Lejeune

Tracking Information
First Submitted Date  ICMJE April 11, 2012
First Posted Date  ICMJE April 12, 2012
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2012)
GMDS ( Griffiths Mental Development Scale) [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01576705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2012)
BL (Brunet Lezine revised scale) [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children
Official Title  ICMJE Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Down Syndrome
Intervention  ICMJE Drug: thyroid hormone and folinic acid
thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
Study Arms  ICMJE
  • Experimental: Thyroxin + folinic acid
    Intervention: Drug: thyroid hormone and folinic acid
  • Active Comparator: Thyroxin+folinic acid placebo
    Intervention: Drug: thyroid hormone and folinic acid
  • Active Comparator: Thyroxin placebo+ folinic acid
    Intervention: Drug: thyroid hormone and folinic acid
  • Placebo Comparator: Thyroxin placebo+ folinic acid placebo
    Intervention: Drug: thyroid hormone and folinic acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2016)
175
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2012)
256
Actual Study Completion Date  ICMJE December 14, 2017
Actual Primary Completion Date December 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01576705
Other Study ID Numbers  ICMJE IJL-AFHT-TH10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Jerome Lejeune
Study Sponsor  ICMJE Institut Jerome Lejeune
Collaborators  ICMJE
  • Hôpital Cochin
  • Central Hospital, Nancy, France
Investigators  ICMJE
Principal Investigator: Clotilde MIRCHER, MD Institut Jerome Lejeune, Paris, France
Study Chair: Franck STURTZ, MD, PhD Department of Biochemistry and Molecular Genetics, Limoges University, Limoges, France
PRS Account Institut Jerome Lejeune
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP