Effect of Antioxidant Docosahexaenoic Acid (DHA) Supplementation in Cystic Fibrosis Patients: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change from Baseline Fatty Acid (FA) profile (percentage) of the erythrocyte membrane at 6 and 12 months
研究概览
简要总结
This study evaluates the effect of antioxidant docosahexaenoic acid (DHA) in patients with cystic fibrosis. Half of participants will receive DHA, while the other half will receive placebo.
详细描述
Several studies show that patients with cystic fibrosis (CF) usually have, compared to the normal population, low levels of linoleic acid (LA) and docosahexaenoic acid (DHA) and increase in arachidonic acid (AA), which is pro-inflammatory. Normalization or modification of this fatty acid pattern (AP) could reduce chronic inflammation. The aim of this study is to assess the effect of oral supplementation with DHA for one year in pediatric patients (6-18 years) with CF, on inflammatory parameters, AP profile, lung function (spirometry) and number of exacerbations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blind study
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders with a diagnosis of cystic fibrosis.
- •FEV1 > 40%.
- •Age between 6 and 18 years.
- •Patients who grant their informed consent or whose representative grants informed consent to participate in the study.
排除标准
- •Pregnant or breastfeeding women
- •Basal oxygen saturation <92% or household supplemental oxygen needs.
- •Massive hemoptysis
- •Patients who are not able to follow or who cannot be assessed in the study according to the protocol.
- •Any circumstance that, at the discretion of the doctor, may involve a clinical risk or harm, the patient's participation in the study or that interferes with the evaluation of the same.
- •Use of systemic glucocorticoids or in the 4 weeks prior to inclusion in the study.
- •Use of non-steroidal anti-inflammatory drugs in the 2 weeks prior to inclusion in the study.
- •Use of investigational drugs or participation in another clinical trial within 30 days prior to inclusion in the study or within the 5 elimination half-lives of the investigational drug.
- •Be already supplementing with Omega -3, fish oil or DHA
研究组 & 干预措施
Antioxidant docosahexaenoic acid (DHA)
Antioxidant docosahexaenoic acid (Tridocosahexaenoin-AOX ® 70%) 50mg/kg/day:
50mg/kg/day so:
- > = 13-17kg: 2 pearls (700mg DHA) every day, once or twice daily (od or bd)
- > = 18-24kg: 3 pearls (1050mg DHA) every day, od or bd
- > = 25-30kg: 4 pearls (1400mg DHA) every day, bd (2-0-2)
- > = 31-36kg: 5 pearls (1750mg DHA) every day, bd (2-0-3)
- > = 37-43kg: 6 pearls (2100mg DHA) every day, bd (3-0-3)
- > = 44-49kg: 7 pearls (2450mg DHA) every day, three times a day (td) (3-1-3)
- > = 50kg: 8 prearls (2800mg DHA) every day, td (3-2-3).
干预措施: ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®) (Dietary Supplement)
Placebo
Olive oil 50mg/kg/day so:
- > = 13-17kg: 2 pearls every day, once or twice daily (od or bd)
- > = 18-24kg: 3 pearls every day, od or bd
- > = 25-30kg: 4 pearls every day, bd (2-0-2)
- > = 31-36kg: 5 pearls every day, bd (2-0-3)
- > = 37-43kg: 6 pearls every day, bd (3-0-3)
- > = 44-49kg: 7 pearls every day, three times a day (td) (3-1-3)
- > = 50kg: 8 prearls every day, td (3-2-3).
干预措施: PLACEBO (OLIVE OIL) (Dietary Supplement)
结局指标
主要结局
Change from Baseline Fatty Acid (FA) profile (percentage) of the erythrocyte membrane at 6 and 12 months
时间窗: baseline, 6 month and 12 month of treatment (end of study)
After blood sampling, erythrocytes are separated from the plasma by centrifugation (2500 rpm for 15 min) and stored at -80ºC until analysed. The fatty acids composition are analyzed by gas chromatography. Fatty acid composition (SFA (saturated FA), MUFA (monoinsatured FA), PUFAs N-6 (polyunsaturated FA omega-6) and PUFAS N-3) are mesured as percentage of total fats.
次要结局
- Change from baseline fecal calprotectin at the 12 months(Baseline and 12 months)
- Change from baseline height at 3, 6, 9 and 12 months(Baseline, 3,6,9 and 12 months)
- Change from Baseline Serum interleukins at 12 months(baseline and 12 month of treatment (end of study))
- Change from baseline pulmonary function at 3,6 ,9 and 12 months(baseline, 3 months, 6 month, 9 months and 12 month of treatment (end of study))
- Number of Pulmonary exacerbation during the study year compared with previous years(12 months prior study, 12 months of the study)
- Adverse reactions during the study(baseline, 3, 6 , 9 and 12 month of treatment (end of study))
- Change from Baseline Esputum interleukins at 6 and 12 months(baseline and 12 months)
- Change from baseline differencial cell counts in sputum at 6 and 12 months.(baseline, 6 months and 12 monts)
- Change from baseline weight at 3, 6, 9 and 12 months(Baseline, 3,6,9 and 12 months)
- Change from baseline body mass index (BMI) at 3, 6, 9 and 12 months(Baseline, 3,6,9 and 12 months)
- Change from Baseline FA ratios of the erythrocyte membrane at 6 and 12 months(baseline, 6 months and 12 months)
研究者
Roser Ayats-Vidal
Principal Investigator
Corporacion Parc Tauli