The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major

• ClinicalTrials.gov Identifier: NCT04260516
• Recruitment Status: Completed
• First Posted: February 7, 2020
• Last Update Posted: February 7, 2020
• Sponsor: Beni-Suef University
• Information provided by (Responsible Party): Heba Mostafa Ahmed, Beni-Suef University

Tracking Information

• First Submitted Date: February 4, 2020
• First Posted Date: February 7, 2020
• Last Update Posted Date: February 7, 2020
• Actual Study Start Date: June 3, 2019
• Actual Primary Completion Date: December 3, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 6, 2020)

• Oxidative stress index (pg/mmol) [ Time Frame: 3 months ]
  Oxidative stress index is calculated as the ratio of total oxidative status (pg/dl) to total anti oxidative capacity (mmol/dl)
• Serum ferritin level ( mg/dl) [ Time Frame: 3 months ]

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major
• Official Title: The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major
• Brief Summary: The effect of N-acetylcysteine as antioxidant and its effect on pretransfusion hemoglobin and iron overload in patients with thalassemia were compared to patients who didn't receive n-acetylcysteine after 3 months of study duration
• Detailed Description: N-acetylcysteine( NAC) is a widely used mucolytic drug and several studies had reported its efficacy as anti oxidant. Patients with thalassemia major are at great risk for oxidative stress due to excess of b-globin chains and iron overload. In this study the investigators compared the effect of NAC on oxidative status , pretransfusion hemoglobin levels and iron overload in thalassemia patients before and after treatment with NAC for 3 months and with that of patients who served as controls.
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two groups are followed up for study parameters for 3 months one group is the intervention group and the other is the control group

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Thalassemia Major

Intervention

Drug: N-acetyl cysteine

Mucolytic and antioxidant drug

Study Arms

• Active Comparator: N-acetylcysteine group
  Patients received oral n-acetylcysteine syrup on dose of 10 mg/kg/day as single dose for 3 months
  Intervention: Drug: N-acetyl cysteine
• No Intervention: Non n-acetylcysteine group
  Thalassemia major patients on regular chelation therapy who didn't receive n-acetylcysteine and served as controls

• Publications *: Ozdemir ZC, Koc A, Aycicek A, Kocyigit A. N-Acetylcysteine supplementation reduces oxidative stress and DNA damage in children with beta-thalassemia. Hemoglobin. 2014;38(5):359-64. doi: 10.3109/03630269.2014.951890. Epub 2014 Sep 15.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 6, 2020): 100
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 30, 2019
• Actual Primary Completion Date: December 3, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Thalassemia major children on regular blood transfusion and iron chelation therapy

Exclusion Criteria:

• Renal or hepatic impairments
• Complicated thalassemia major
• Non adherence to therapy or follow up visits
• Change in the iron chelation dose within 3 months before enrollment or during study period

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years to 14 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04260516
• Other Study ID Numbers: FM-BSU REC
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Heba Mostafa Ahmed, Beni-Suef University
• Original Responsible Party: Same as current
• Current Study Sponsor: Beni-Suef University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Heba M Ahmed; Beni-Suef University

• PRS Account: Beni-Suef University
• Verification Date: February 2020