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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01576705
First Posted: April 12, 2012
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ascopharm (CRO)
Effi-stat (CRO)
AnticipSante (CRO)
LC2 (CRO)
BIOMNIS Central laboratory
UMR INSERM 1124
Laboratoire de Biochimie Biologie Moléculaire Nutrition Métabolisme CHU Brabois (Unité Inserm 954)
Information provided by (Responsible Party):
Institut Jerome Lejeune
  Purpose

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.

Condition Intervention Phase
Down Syndrome Drug: thyroid hormone and folinic acid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children

Resource links provided by NLM:


Further study details as provided by Institut Jerome Lejeune:

Primary Outcome Measures:
  • GMDS ( Griffiths Mental Development Scale) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • BL (Brunet Lezine revised scale) [ Time Frame: 12 months ]

Estimated Enrollment: 175
Actual Study Start Date: April 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 7, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thyroxin + folinic acid Drug: thyroid hormone and folinic acid
thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
Active Comparator: Thyroxin+folinic acid placebo Drug: thyroid hormone and folinic acid
thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
Active Comparator: Thyroxin placebo+ folinic acid Drug: thyroid hormone and folinic acid
thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
Placebo Comparator: Thyroxin placebo+ folinic acid placebo Drug: thyroid hormone and folinic acid
thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576705


Locations
France
Institut Jerome Lejeune
Paris, France, 75015
Sponsors and Collaborators
Institut Jerome Lejeune
Ascopharm (CRO)
Effi-stat (CRO)
AnticipSante (CRO)
LC2 (CRO)
BIOMNIS Central laboratory
UMR INSERM 1124
Laboratoire de Biochimie Biologie Moléculaire Nutrition Métabolisme CHU Brabois (Unité Inserm 954)
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Institut Jerome Lejeune
ClinicalTrials.gov Identifier: NCT01576705     History of Changes
Other Study ID Numbers: IJL-AFHT-TH10
First Submitted: April 11, 2012
First Posted: April 12, 2012
Last Update Posted: October 10, 2017
Last Verified: October 2017

Keywords provided by Institut Jerome Lejeune:
Down syndrome
Young children
Psychomotor development
Thyroid hormone
Folinic acid
Psychometric tests
GMDS
Griffiths
Genetic factors
Biochemical factors

Additional relevant MeSH terms:
Syndrome
Down Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Hormones
Leucovorin
Levoleucovorin
Folic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Hematinics