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Gum Arabic as Anti-oxidant, Anti-inflammatory and Fetal Hemoglobin Inducing Agent in Sickle Cell Anemia Patients (GA&SCA)

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ClinicalTrials.gov Identifier: NCT04191213
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
University of Khartoum
Information provided by (Responsible Party):
Lamis Kaddam, Al-Neelain University

Tracking Information
First Submitted Date  ICMJE December 5, 2019
First Posted Date  ICMJE December 9, 2019
Last Update Posted Date January 28, 2020
Estimated Study Start Date  ICMJE February 15, 2020
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2019)
  • Fetal hemoglobin level after 12 weeks [ Time Frame: 12 weeks ]
    Measure increase from the baseline values
  • Total anti oxidant capacity [ Time Frame: 12 weeks ]
    Measure increase from the baseline values
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2020)
Anti inflammatory marker C reactive Protein [ Time Frame: 12 weeks ]
Measure decrease from the baseline values
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2019)
Anti inflammatory marker C reactive Protein [ Time Frame: 12 weeks ]
Measure increase from the baseline values
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gum Arabic as Anti-oxidant, Anti-inflammatory and Fetal Hemoglobin Inducing Agent in Sickle Cell Anemia Patients
Official Title  ICMJE Efficacy of Gum Arabic as Anti-oxidant, Anti-inflammatory and Fetal Hemoglobin Inducing Agent in Sickle Cell Anemia Patients : A Randomized, Double-blind, Two-armed Parallel-group, Placebo-controlled Phase II/III Study - Khartoum, Sudan
Brief Summary To study the efficacy of Gum Arabic as an anti-oxidant, anti-inflammatory and Fetal Hemoglobin-inducing agent among Sickle Cell Disease children. Half of participants will receive Gum Arabic and the other half will receive placebo
Detailed Description Polymerized hemoglobin is injurious to the red cell membrane, resulting in oxidative damage in sickle cell disease . Fetal hemoglobin is protective against sickling and its decrease is associated with vaso-occlusive crisis . Gum Arabic is soluble fibers with prebiotic properties. It increased the level of serum butyrate which is short chain fatty acid. The latter proved to serve as fetal hemoglobin inducing agent both in vivo and in vitro study. And also has strong anti-inflammatory properties. So our aim to test whether oral digestion of Gum Arabic will induce fetal hemoglobin among sickle cell pediatric patients
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The intervention group will receive Gum Arabic. And The placebo group will receive pectin
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participants, care providers, Investigator and outcome assessor will be masked regarding the type of intervention each group will receive
Primary Purpose: Supportive Care
Condition  ICMJE Sickle Cell Anemia in Children
Intervention  ICMJE
  • Dietary Supplement: Acacia Senegal extract
    Oral Digestion of Gum Arabic to be consumed early morning in daily basis for 12 weeks
    Other Name: (Gum Arabic)
  • Dietary Supplement: Pectin
    Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks
Study Arms  ICMJE
  • Experimental: Intervention Group
    This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose for participants above 5 years of age and 15-grams-dose for participants below 5 years of age for 12 weeks
    Intervention: Dietary Supplement: Acacia Senegal extract
  • Placebo Comparator: Control group
    This group will be provided with pectin powder provided as one-gram-dose for children below 5 years of age & two-gram-dose for children above 5 years of age
    Intervention: Dietary Supplement: Pectin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2020
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Homozygous for Sickle Cell Disease (SS) as documented by Haemoglobin electrophoresis.

Subjects whom medications and dosages had been stable for 2 weeks before study entry.

Subjects who have not received blood transfusion or had acute episode related to sickle cell disease in the last two weeks before the start of intervention.

Exclusion Criteria:

  • Patients with history of Gum Arabic allergy. Patients who have ischemic heart disease, liver dysfunction or hepatitis. Pregnant female patients who plan to conceive in the next 4 months and fertile female patients who are not using an effective contraception method.

Patients who are currently using Gum Arabic. Patients who are on steroids or chemotherapy.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dalya MM Abdelmaged, MBBS 00249126831595 dalya.alfeel@gmail.com
Contact: Lamis AA KAddam, PhD +249912979736 lamiskaddam@hotmail.com
Listed Location Countries  ICMJE Sudan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04191213
Other Study ID Numbers  ICMJE GA& Sickle among children
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Share patients data without personal data and without breaching confidentiality
Responsible Party Lamis Kaddam, Al-Neelain University
Study Sponsor  ICMJE Al-Neelain University
Collaborators  ICMJE University of Khartoum
Investigators  ICMJE
Study Director: Imad M Fdl-Elmula, PhD Alneelain University
PRS Account Al-Neelain University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP