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Trial record 1 of 2 for:    linoleic acid | cystic fibrosis
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NETwork of Linoleic Acid Supplementation in Cystic Fibrosis (NETLACF)

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: NCT04531410
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2020
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
European Society of Pediatric Gastroenterology, Hepatology and Nutrition
Information provided by (Responsible Party):
Birgitta Strandvik, MD, PhD, Karolinska Institutet

Brief Summary:

Undernutrition is a common problem in patients with cystic fibrosis (CF) despite international consensus that the patients shall be given 120-200% of energy recommendations. Studies imply that one problem might be that the patients are not compensated for the essential fatty acid deficiency (linoleic acid, LA), which is well known in these patients. This deficiency is shown not to be due to fat malabsorption, but related to an increased turnover of arachidonic acid, a transformation product of LA. This abnormality is related to mutations associated with a more severe clinical phenotype. The most common and typical symptom of LA deficiency is poor growth. Studies in animals have further indicated that many of the symptoms in CF are related to the deficiency. A series of recent prospective studies from Wisconsin corroborate the importance of LA for growth. In Sweden LA has been supplemented to most patients since the late 70´, and the condition of patients have been among the leading in the world regarding growth, pulmonary function and survival. Short-term studies have shown better effect of LA supplementation compared to similar supply of energy without including extra LA. There are few long-term studies, performed before the gene was identified, giving very heterogeneous patient groups in regard to genotype, but with some positive results on growth and physiology. It´s of interest that modern personalized extremely expensive therapy with correctors and potentiators for Cystic Fibrosis Transmembrane Conductance Regulator may influence lipid metabolism. LA might thus tentatively be a cheap adjuvant to this modern therapy, but this has to be specially studied.

The aim of the study is to find if there are differences in clinical and metabolic outcome between two groups, blindly given similar amount of extra calories, in one group consisting of linoleic acid.The benefit for the patients would be great if the expected positive effect can be proved in the planned study. The treatment will be cheap and without adverse effects. From socioeconomic point of view is would be a great advantage.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Supplement: linoleic acid supplementation Dietary Supplement: oleic acid supplementation Not Applicable

Detailed Description:
Two group of matched children with CF were randomized to two type of oils given 20 g oil and 600 mg DHA daily for one year and anthropometry, pulmonary function, biochemistry, resting energy expenditure, lipid mediators, inflammatory and intestinal markers were studied at start and at 6 months and 1 year. Dietary intake was controlled and life quality recording at start and end of study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel, double blind, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The supplement only differ by colour on capsulae, no labelling
Primary Purpose: Treatment
Official Title: Double-blind Randomized Controlled Study of Linoleic Acid Supplementation for 1 Year in Patients With Cystic Fibrosis - Influence on Clinical Status and Metabolism
Actual Study Start Date : October 25, 2021
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Linoleic
Linoleic acid 13 g and 600 mg algal docosahexaenoic acid (DHA)
Dietary Supplement: linoleic acid supplementation
Oils given daily at morning meal with extra enzymes

Active Comparator: Oleic
Oleic acid 13 g and 600 algal DHA
Dietary Supplement: oleic acid supplementation
Oils given at morning meal with extra enzymes




Primary Outcome Measures :
  1. Growth [ Time Frame: 1 year ]
    change in BMI, standard deviation score (SDS)

  2. Weight [ Time Frame: 1 year ]
    change in SDS body weight

  3. Height [ Time Frame: 1 year ]
    change in SDS height


Secondary Outcome Measures :
  1. Pulmonary function [ Time Frame: 1 year ]
    change in forced expiratory volume in one second (FEV1 % of predicted)

  2. Quality of life, the patient experience of well being [ Time Frame: 1 year ]
    Questionaire about health, physical activity, well being (8 items), CFQ-child + CFQ- parents (higher rates are better) The score changes are analysed.The CFQ considers the physical, image, digestive, respiratory, emotional, social, food, treatment, vitality, health, social role and weight domains. Each domain has a score and its sum generates the total score, whose values can vary from 0 to 100 The scores will also be related to measurements.


Other Outcome Measures:
  1. Lipid mediators [ Time Frame: 1 year ]
    change in lipid mediators in blood and urine, ion trap- Mass Spectrometry, picoMol (> 150 products of both the n-6 and n-3 series)

  2. Clinical infectious status [ Time Frame: 1 year ]
    change in number exacerbations compare to previous year,

  3. Influence on sodium status [ Time Frame: 1 year ]
    change in Sodium in sweat test, mol/L and urine (fractional sodium excretion)

  4. Inflammatory markers [ Time Frame: 1 year ]
    change in Cytokines, Proximity extension assays (PEA proteomics) picogram/ml

  5. Metabolic marker [ Time Frame: 1 year ]
    Change in serum insulin growth factor -1 (IGF-1, nanogram/ml)

  6. Energy metabolism [ Time Frame: 1 year ]
    Change in resting energy expenditure (REE/kg body weight)

  7. Bone mineral density [ Time Frame: 1 year ]
    Change in total bone mineral density by dual x-ray absorptiometry (DXA), gram/cm^2

  8. Oral glucose tolerance [ Time Frame: 1 year ]
    Measure of glucose and insuline after oral glucose loading



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Try to have similar number of participants of the same sex and age for randomization
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Two mutations related to severe clinical status such as dF508, or other stop mutations or class II mutations. Severe status includes pancreatic insufficiency

Exclusion Criteria:

  • Liver cirrhosis and/or portal hypertension, transplantation or on transplantation list, intake of lipid supplements the latest 2 months

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): NCT04531410


Locations
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Italy
Centro Regionale di Supporto per la Fibrosei Cistica, ASST Spedali civili, Univ of Brescia
Brescia, Brescia - Lombardia, Italy, 25123
Università degli Studi di Milan
Milan, Italy
Norway
Norwegian Resourse Center for Cystic Fibrosis, Oslo University Hospital
Oslo, Norway
Poland
Poznan University of Medical Sciences
Poznań, Poland
Sweden
Center of Cystic fibrosis, Dept of Pediatrics, Lund University Hospital
Lund, Skåne, Sweden, 22242
Sponsors and Collaborators
Karolinska Institutet
European Society of Pediatric Gastroenterology, Hepatology and Nutrition
Investigators
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Principal Investigator: Jaroslaw Walkowiak, MD,PhD University of Poznan, CF center, Poland
Principal Investigator: Carla Colombo, MD,PhD University of Milan, CF center, Italy
Principal Investigator: Egil Bakkeheim, MD, PhD University of Oslo, CF center, Norway
Principal Investigator: Raffaele Badolato, MD, PhD University of Brescia, CF center, Italy
Principal Investigator: Christine Rönne-Hansen, Md, PhD Lund University, CF center, Sweden
  Study Documents (Full-Text)

Documents provided by Birgitta Strandvik, MD, PhD, Karolinska Institutet:
Study Protocol  [PDF] August 18, 2020

Publications:
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Responsible Party: Birgitta Strandvik, MD, PhD, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04531410    
Other Study ID Numbers: 2020-02871
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The results will be anonymous and reported to peer review journals for publication. Beside the local PIs there will be other local staff involved and for the analyses also co-workers as shown in the study protocol which will be attached for review.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Birgitta Strandvik, MD, PhD, Karolinska Institutet:
arachidonic acid,
lipid mediators
cytokines
growth
pulmonary function
IGF-1
resting energy expenditure
docosahexaenoic acid
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases