Evaluation of using curcumin as a nutritional strategy on clinical finding and inflammatory markers in children with cystic fibrosis
- Conditions
- Cystic Fibrosis.Other chronic obstructive pulmonary disease
- Registration Number
- IRCT20200705048018N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
One or more typical phenotypic features of CF and a minimum of an elevated sweat chloride concentration on two/more occasions or two mutations known to cause CF on separate alleles
Age of 5-18 years
Pulmonary and gastrointestinal involvement
Ability to perform spirometry maneuvers and the minimum FEV1 of =30% compared to the same age, gender, and height in the normal population
The percentage of oxygen saturation based on pulse oximetry of =90% at room temperature
No cardiovascular, hepatic, and renal failure
Absence of celiac disease and rheumatoid arthritis
No acute pulmonary exacerbation requiring hospitalization within the past four weeks
Absence of acute respiratory tract infection
Informed consent for participation
The lack of adherence to the drug regimen
Presence of drug intolerance
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Inflammation at three levels: Systemic Inflammation, Pulmonary Inflammation, Gastrointestinal Inflammation. Timepoint: Before and after three months of trial. Method of measurement: 1) Systemic inflammation by assessing IL-8 as an inflammatory agent, IL-10 as an anti-inflammatory agent, and hsCRP level in the blood samples; 2) Pulmonary inflammation with the neutrophil count, and bacterial/viral culture on the nasopharyngeal swab; 3) Gastrointestinal inflammation with the calprotectin level in the fecal samples.
- Secondary Outcome Measures
Name Time Method Evaluation of pulmonary function. Timepoint: Before and after three months of trial. Method of measurement: Spirometer.;Quality of life. Timepoint: Before and after three months of trial. Method of measurement: Cystic Fibrosis Questionnaire(CFQ).