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Quantitative Requirements of Docosahexaenoic Acid for Neural Function in Children With Phenylketonuria

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.
 
ClinicalTrials.gov Identifier: NCT00909012
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich

Tracking Information
First Submitted Date  ICMJE April 22, 2009
First Posted Date  ICMJE May 27, 2009
Last Update Posted Date June 1, 2018
Study Start Date  ICMJE May 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2009)
latency of visually evoked potentials [ Time Frame: assessed basally (before intervention start) and at the end of the 6 month intervention period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2009)
  • fatty acid composition of plasma phospholipids [ Time Frame: assessed basally (before intervention start) and at the end of the 6 month intervention period ]
  • fine motor skills [ Time Frame: assessed basally (before intervention start) and at the end of the 6 month intervention period ]
  • test of reaction time [ Time Frame: assessed basally (before intervention start) and at the end of the 6 month intervention period ]
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 Quantitative Requirements of Docosahexaenoic Acid for Neural Function in Children With Phenylketonuria
Official Title  ICMJE Quantitative Requirements of Docosahexaenoic Acid for Neural Function in Children With Phenylketonuria
Brief Summary

Patients with phenylketonuria (PKU) have an inborn error in the metabolism of the amino acid phenylalanine (Phe) and thus must follow a strictly controlled protein-restricted diet from early infancy. This protein-restricted diet is devoid of natural dietary sources of n-3 long chain polyunsaturated fatty acids (LC-PUFA), such as eggs, meat, milk or fish. Therefore, blood concentrations of n-3 LC-PUFA, especially of docosahexaenoic acid (DHA) are reduced in PKU children compared to healthy controls. DHA availability is considered important for optimal neurological function. Previous studies have shown that neural function of PKU children is improved by high dose supplementation of fish oil providing DHA, as shown by significant improvements of both visual evoked potential latencies and of fine motor skills and coordination, but no dose response relationship has been established so far.

This multicentric double-blind randomized trial aims at determining quantitative DHA requirements for optimal neural function in PKU children. Patients with classical PKU from several major treatment centers in Europe will be randomized to receive between 0 and 8 mg of DHA per kg body weight daily for a duration of 6 months. Biochemical (fatty acid composition of plasma phospholipids, lipoprotein metabolism and metabolic profiles), and functional testing (visual evoked potentials, fine motor skills, cognitive function and markers of immune function) will be performed at baseline and after 6 months. Intake per kg body weight will be related to outcome parameters and thus a possible dose response relationship will be defined. The results from this study are expected to contribute to the improvement of the diet of PKU patients, but they also have the potential to help defining quantitative DHA needs of healthy children.

The primary hypothesis is that supplementation with DHA improves visual function in children with PKU.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Phenylketonuria
Intervention  ICMJE
  • Dietary Supplement: high oleic sunflower oil
    placebo, which does not provide DHA
  • Dietary Supplement: microalgal oil
    the supplement provides 20 mg DHA per capsule (1 or 2 are consumed per day, depending on body weight)
  • Dietary Supplement: microalgal oil
    the supplement provides 40 mg DHA per capsule (1 or 2 are consumed per day, depending on body weight)
  • Dietary Supplement: microalgal oil
    the supplement provides 80 mg DHA per capsule (1 or 2 are consumed per day, depending on body weight)
  • Dietary Supplement: microalgal oil
    the supplement provides 130 mg DHA per capsule (1 or 2 are consumed per day, depending on body weight)
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Dietary Supplement: high oleic sunflower oil
  • Experimental: 2
    Intervention: Dietary Supplement: microalgal oil
  • Experimental: 3
    Intervention: Dietary Supplement: microalgal oil
  • Experimental: 4
    Intervention: Dietary Supplement: microalgal oil
  • Experimental: 5
    Intervention: Dietary Supplement: microalgal oil
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: June 19, 2014)
114
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2009)
125
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children with classical PKU, who have been diagnosed and treated from the newborn period onwards
  • Classical PKU must have been established by a baseline plasma phenylalanine (PHE) level >1200 µmol/L or detection of underlying mutations
  • Children are clinically healthy besides classical PKU
  • Good metabolic control (a minimum of 2 Phe-values during the last 6 months are needed with average Phe values being below 480 µmol/L in the last 6 months)
  • No n-3 LC-PUFA supplementation for at least 6 months before enrolment
  • Written informed consent of parents exists

Exclusion Criteria:

  • Severe neurological symptoms
  • History of neurological disease
  • Children are unable to take DHA-capsules regularly
  • Acute illness, especially infections at the time of clinical examination/testing
  • Children with weight/height over the 97th percentile or below the 3rd percentile
  • Known hypersensitivity to fish oil products
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00909012
Other Study ID Numbers  ICMJE 455-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich
Study Sponsor  ICMJE Ludwig-Maximilians - University of Munich
Collaborators  ICMJE European Union
Investigators  ICMJE
Principal Investigator: Berthold Koletzko, Prof. Dr. von Hauner Children Hospital, Ludwig-Maximilians-Universitaet Muenchen
PRS Account Ludwig-Maximilians - University of Munich
Verification Date May 2018

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