An interventional study of Lipano formula in Fatty Acid Oxidation Disorder, sponsored by Dr. Schär AG / SPA. Completed at 1 site in Russian Federation. Open to participants aged Up to 18 Months. Per ClinicalTrials.gov, last updated 2020-05-22.
Sponsored by Dr. Schär AG / SPA · Not applicable, Interventional, and Basic science
This is a market research, observational study to evaluate the tolerability and acceptability of an MCT based formula for infants and young people with long chain fatty acid oxidation disorder from birth to 18 months. Patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including MCT will be included in this study
Dr. Schär AG / SPA is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Kanso Lipano will be consumed daily for 3 months each to assess tolerability and compliance
Dietary Supplement: Lipano formula
Subjects will be asked to take an MCT infant formula to assess the tolerability, compliance and overall acceptability of the product for patient with LCHAD
Gastrointestinal tolerance: questionnaire
Daily questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product
Time frame: 90 days
Product compliance
Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Time frame: 90 days
Product palatability
Questionnaire data captured to evaluate taste
Time frame: 90 days
Product acceptability
Brief tick-box questionnaire on overall liking and acceptability of product
Time frame: 90 days
Biochemistry stability - creatine kinase
creatine kinase will be monitored
Time frame: 90 days
Biochemistry stability - liver enzymes
liver enzymes will be monitored
Time frame: 90 days
Anthropometry 1
weight in g monitored to check growth
Time frame: 90 days
Anthropometry 2
height in cm monitored to check growth
Time frame: 90 days
Plan to share: No — This study will be used to demonstrate acceptability for registration and reimbursement of these foods for special medical purposes.
No publications or documents are linked to this record.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Dr. Schär AG / SPA