NCT06875050

Antioxidant Supplements in Cystic Fibrosis Children

Effect of Antioxidant Supplements on Oxidative Stress, Disease Severity and Bacterial Infection in Cystic Fibrosis Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cystic Fibrosis (CF)

Interventions

Type	Name	Description
OTHER	Mediterranean diet	Tailored dietary plan following Mediterranean diet to cover macronutrients needs according to recommended daily allowance (RDA) for age
DIETARY_SUPPLEMENT	Fat soluble vitamins supplementation	Fat soluble vitamins supplementation (150 μg vitamin A, 2000 IU vitamin D, 100 mg vitamin E and 1000 μg vitamin K).
DIETARY_SUPPLEMENT	Antioxidant Supplement	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).

Timeline

• Start date: 2024-03-12
• Primary completion: 2025-02-13
• Completion: 2025-03-01
• First posted: 2025-03-13
• Last updated: 2025-03-13

Locations

1 site across 1 country: Egypt