Pediatric and adolescent patients with Cystic Fibrosis.
Conditions
Interventions
Supplementation with fish oil capsules containing 180mg of fatty acid eicosapentaenoic (EPA) and 120mg of docosahexaenoic acid (DHA), in quantities of 20 to 30 mg/kg, for six months in all patients wi
Dietary supplement
SP6.051.227
Sponsors
Instituto Nacional de Saúde da Mulher da Criança e do Adolescente Fernandes Figueira
Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro
Eligibility
Age
5 Years to 19 Years
Inclusion criteria
Inclusion criteria: Patients with cystic fibrosis, between 5 and 19 years of age, attended the National Institute of Women's Health Child and Teenagers Fernandes Figueira.
Exclusion criteria
Exclusion criteria: Patients with liver disease, steatorrhea, diarrhea and vomiting uncontrolled, exacerbation of the disease, indicating lung transplant, pregnant teens, and patients without adherence to medication and nutrition treatment, patients using supplements with omega-3 within 3 months before the study began.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of fatty acids in erythrocyte by gas chromatography conducted every three months for one year. It is expected that fish oil supplementation promotes the incorporation of fatty acids in erythrocytes by improving the imbalance between fatty acids generally observed in patients with cystic fibrosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of anthropometric indicators (body mass index/age and height/age) and the body composition (arm muscle circumference, triceps skinfold and body fat percentage) by measurement of weight, height, arm circumference and triceps skinfold every three months for a year to evaluate anthropometric and in body composition with fish oil supplementation. Evaluation the intake of energy and macronutrients (carbohydrates, proteins, fats and fatty acids) by 24 hour recall every three months for one year and check for possible changes with the intervention. Assessment of disease severity by clinical score Shwachman-Kulczycki, every three months for a year, this score is divided into four categories (general activity, physical examination, nutrition and radiographic findings) to evaluate clinical changes during the study. Data on bacterial colonization obtained from patients records based on the results of cultures of airway (sputum) every three months for a year to assess changes in infection with the intervention. To evaluate length of hospital one year before, during and after the study and verify possible changes after the intervention from patients records. Dosages of inflammatory markers (TNF-alpha, interleukins (IL-1 beta, IL-6 and IL-8) PGE2 and LTB4 in blood plasma by ELISA (enzyme-linked immuno sorbent assay) based on antigen-antibody reactions detectable by enzyme reaction (enzyme immunoassay)to assess the inflammatory status every three months during the study. | — |
Countries
Brazil
Contacts
Public ContactCélia Regina Chaves
Instituto Nacional de Saúde da Mulher da Criança e do Adolescente Fernandes Figueira
Outcome results
None listed