Antioxidant Supplements in Cystic Fibrosis Children

NCT06875050 | Completed

• 1 other identifier: FMASU MS 98/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• evaluate the effect of antioxidants supplementation on the level of oxidative stress among CF children..

  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.

  6 months

Study Arms (2)

Arm 1(Extra care group)

EXPERIMENTAL

Other: Mediterranean diet; Dietary Supplement: Antioxidant Supplement

Arm 2

ACTIVE COMPARATOR

Other: Mediterranean diet; Dietary Supplement: Fat soluble vitamins supplementation

Interventions

Mediterranean diet OTHER

Tailored dietary plan following Mediterranean diet to cover macronutrients needs according to recommended daily allowance (RDA) for age

Arm 1(Extra care group); Arm 2

Fat soluble vitamins supplementation DIETARY_SUPPLEMENT

Fat soluble vitamins supplementation (150 μg vitamin A, 2000 IU vitamin D, 100 mg vitamin E and 1000 μg vitamin K).

Arm 2

Antioxidant Supplement DIETARY_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).

Arm 1(Extra care group)

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients with current pulmonary exacerbations.
• Patients with severe sepsis.
• Patients with comorbid systemic illnesses.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 1181, Egypt

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatrics

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 13, 2025
• Study Start: March 12, 2024
• Primary Completion: February 13, 2025
• Study Completion: March 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

EG (1)