NCT06875050Completed
Antioxidant Supplements in Cystic Fibrosis Children
Effect of Antioxidant Supplements on Oxidative Stress, Disease Severity and Bacterial Infection in Cystic Fibrosis Children
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
This randomized controlled clinical trial included 60 pediatric patients with cystic fibrosis (CF) assigned randomly into two arms; Arm 1(extra care arm):received a tailored dietary plan following Mediterranean diet to cover macronutrients needs according to recommended daily allowance (RDA) for age, with antioxidant supplements in specific doses in oral liquid form (200 mg vitamin E, 300 mg vitamin C, 90 μg Se, 500 μg vitamin A, 30 mg zinc, 3 mg copper and 2000 IU vitamin D) for 6 months. Arm 2: recieved tailored dietary plan following Mediterranean diet as Arm 1 with fat soluble vitamins supplementation (150 μg vitamin A, 2000 IU vitamin D, 100 mg vitamin E and 1000 μg vitamin K) for 6 months. This study aimed to evaluate the effect of antioxidants supplementation on the level of oxidative stress, as measured by 3-Nitrotyrosine, bacterial colonization and diseases severity among CF children.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 8 Mar 2025
- Start date
- 12 Mar 2024
- Primary completion date
- 13 Feb 2025
- Lead sponsor
- Ain Shams University
- Diseases
- Cystic fibrosis
- NCT number
- NCT06875050
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 12 Mar 2024 to the primary completion date, 13 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with comorbid systemic illnesses.
Other
- Patients with current pulmonary exacerbations.
- Patients with severe sepsis.
Who the study is looking for
- Patients with documented diagnosis of cystic fibrosis (CF) who were diagnosed according to CF Foundation guidelines based upon positive sweat tests and/or the presence of a mutation in the homozygous state or two heterozygous mutations on the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein
Age in the registry: 6 months to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ain Shams University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.