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Patients with Cystic Fibrosis have increased oxidative stress and impaired antioxidant systems. Under certain conditions, docosahexaenoic acid (DHA) intake may have a favorable role in reducing redox status.
In this randomized, double-blind, cross-over study, DHA (Pro-Mind) and placebo (sunflower oil) capsules, will be given, daily to 10 patients, 5 mg/kg for 2 weeks then 10 mg/kg for the next 2 weeks. Biomarkers of lipid peroxidation and vitamin E levels will be measured. Plasma and platelet lipid compositions will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docosahexaenoic acid | Experimental | Each capsule of DHA contains 100 mg DHA in triglycerides from algal oil, 0.125 mg alpha-tocopherol and 0.125 mg ascorbic acid. Subjects receive an orally and daily ingestion of DHA capsules (5mg/kg for 15 days followed by 10 mg/kg for another 15 days without interruption between the 2 periods). |
|
| Sunflower oil | Placebo Comparator | Placebo capsules contain the same quantities of antioxidants and triglycerides of sunflower oil. Subjects receive an orally and daily ingestion of placebo capsules for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docosahexaenoic acid | Drug |
| ||
| Sunflower Oil |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 8-isoprostane level in urine. | Measured by urinalysis (Immunoassay). | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 11-dehydro-thromboxane B2 in urine. | Measured by urinalysis (Immunoassay). | Day 28 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Measured by vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27914512 | Result | Vericel E, Mazur S, Colas R, Delaup V, Calzada C, Reix P, Durieu I, Lagarde M, Bellon G. Moderate intake of docosahexaenoic acid raises plasma and platelet vitamin E levels in cystic fibrosis patients. Prostaglandins Leukot Essent Fatty Acids. 2016 Dec;115:41-47. doi: 10.1016/j.plefa.2016.10.008. Epub 2016 Oct 18. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D000074242 | Sunflower Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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|
| Day 28 |
| Change in percent predicted forced expiratory volume in 1 second | Spirometry | from baseline through Day 28 |
| Evaluation of the effect of DHA on specific biomarkers. | Gas chromatography, immunoassays, fluorimetry. (in plasma : lipids, vitamin E and in platelet : lipids, vitamin E, thromboxane B2, malondialdehyde). | Day 28 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |