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Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy (MITOX)

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ClinicalTrials.gov Identifier: NCT02385565
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE March 2, 2015
First Posted Date  ICMJE March 11, 2015
Last Update Posted Date March 11, 2015
Study Start Date  ICMJE February 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
resting energy expenditure [ Time Frame: up to 3 months ]
resting energy expenditure measured by indirect calorimetry
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
  • diet induced thermogenesis [ Time Frame: baseline, 1 month, 2 months, 3 months ]
    diet induced thermogenesis measured by indirect calorimetry
  • body composition [ Time Frame: baseline, 1 month, 2 months, 3 months ]
    body composition by DEXA
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 Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy
Official Title  ICMJE Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy
Brief Summary

The aim of the present study is to compare Resting Energy Expenditure (REE) between normal fat diet (NFD) as a control vs high fat diet (HFD) as a treatment in Mitochondrial cytopathies disorders ( MID's ) patients. Secondary objectives is to compare diet induced thermogenesis (DIT) and body composition between NFD vs HFD.

This study is a randomized cross-over study. Normal fat diet (ie 10 % proteins, 45 % lipids, 45 % carbohydrates) is the imposed diet at baseline, high fat diet (ie 10 % proteins, 30 % lipids, 60 % carbohydrates is used according to the cross-over design trial. Main evaluation criteria is REE and second evaluation criteria is DIT both measured by indirect calorimetry ). 36 included MID subjects will be included in this study. Main evaluation criteria and second evaluation criteria will be measured at baseline, 1 month, 2 month and 3 month.

Detailed Description REE and DIT are measured by indirect calorimetry . The device used is a using an open-circuit ventilated hood system (QUARK RMR®, Cosmed, Pavona; Italy). The respiration quo- tient (RQ) and flow settings are calibrated by reference to alcohol combustion every six months. Before each test, the calorimeter is calibrated with a reference gas mixture (5% CO2, 95% O2 v/v). Expired carbon di- oxide (VCO2) and inspired oxygen (VO2) -flows are recorded, as well as the RQ. EE is calculated every minute from oxygen consumption (VO2 in ml/min) and carbon dioxide production (VCO2 in ml/min) using the Weir formula without protein correction. DIT is measured during 6 hours after a calibrated breakfast (normal fat diet or high fat diet according to the cross-over design) as 30% of theoric energy intake.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitochondrial Cytopathies Disorders
Intervention  ICMJE
  • Other: high fat diet
    high fat diet as 10 % proteins, 30 % lipids, 60 % carbohydrates
  • Other: normal fat diet
    high fat diet as 10 % proteins, 45 % lipids,45 % carbohydrates
Study Arms  ICMJE
  • Experimental: high fat diet
    10 % proteins, 30 % lipids, 60 % carbohydrates
    Intervention: Other: high fat diet
  • Placebo Comparator: Normal fat diet
    10 % proteins, 45 % lipids, 45 % carbohydrates
    Intervention: Other: normal fat diet
Publications * Not Provided

*   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: March 10, 2015)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 5 to 21 years-old children,

    • Children with a proven mitochondrial cytopathy documented on biopsies by histology, histoenzymology, ultrastructure and enzyme assay and/or on body fluids by laboratory markers including lactacidemia, metabolic acidosis, increased CSF lactate, lactate/pyruvate and beta-hydroxybutyrate/acetoacetate ratios, paradoxical postprandial ketonemia, alaninemia, citrullinemia, plasma acylcarnitines.
    • Children on the usual diet (30% lipids, 60% glucides and 10% proteins) for at least 1 month.
    • Informed consent of the 2 parents and from the child when in age to express a consent.
    • Child with a social security cover.

Exclusion Criteria:

  • Acute infection (fever > 38.5°C for more than 6h) within 7 days prior to the study.
  • Disability for understanding and following the protocol
  • Rejection of the study by the patient or failure to comply to the protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 21 Years   (Child, Adult)
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 NCT02385565
Other Study ID Numbers  ICMJE 2004/0401
2004/0138 ( Other Identifier: DGS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Dries DOBBELAERE, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date March 2015

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