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Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

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ClinicalTrials.gov Identifier: NCT02467257
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : June 10, 2015
Sponsor:
Collaborators:
Military hospital
Ministry of Higher Education and Scientific Research, Republic of Sudan
Information provided by (Responsible Party):
Lamis Kaddam, Al-Neelain University

Tracking Information
First Submitted Date  ICMJE June 4, 2015
First Posted Date  ICMJE June 10, 2015
Last Update Posted Date June 10, 2015
Study Start Date  ICMJE April 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2015)
The primary endpoint of the study will be the level of fetal hemoglobin after three months [ Time Frame: 12 weeks ]
fetal hemoglobin will be measured each month for three months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia
Official Title  ICMJE Potential Role of Gum Arabic as Fetal Hemoglobin Agent in Sudanese Sickle Cell Anemia Patients
Brief Summary The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin inducing agent for sickle cell anemia patients.
Detailed Description : High level of fetal haemoglobin (Hb F) decreases sickle cell anaemia (SCA) severity and leads to improved survival. Butyrate proved to increase HbF production in vivo and in vitro studies. Nonetheless, its short half-life limited its utilization in clinical practice. Gum Arabic (GA) is edible, dried, gummy exudate from Acacia Senegal tree. GA fermentation by colonic bacteria increases serum butyrate concentrations. The investigators hypothesized regular intake of GA will increase serum butyrate level. The latter will induce fetal hemoglobin production and ameliorate patients' symptoms. 47 patients hemoglobin SS aged 5-42 years, on regular follow up in Military hospital were recruited from April 2014 to January 2015 Patients received dose of G A 30g/day for 12 weeks. Hb F, complete blood count and Erythropoietin level were measured. The main outcome of interest was the level of HbF after 12 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Anemia
Intervention  ICMJE Dietary Supplement: Gum Arabic
oral ingestion of 30 gram every day for 12 weeks
Study Arms  ICMJE Experimental: Intrevention arm
Patients received Gum Arabic as intervention
Intervention: Dietary Supplement: Gum Arabic
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2015)
47
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. over 5 year old
  2. less t5han 50
  3. diagnosed with homozygous sickle cell anemia by Hb electrophoresis

Exclusion Criteria:

1. patients received blood transfusion within the last three months or admitted to the hospital within 2 weeks because of Sickle cell anemia -related events or crisis.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sudan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02467257
Other Study ID Numbers  ICMJE AlNeelainU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lamis Kaddam, Al-Neelain University
Study Sponsor  ICMJE Al-Neelain University
Collaborators  ICMJE
  • Military hospital
  • Ministry of Higher Education and Scientific Research, Republic of Sudan
Investigators  ICMJE
Study Director: Amal M Saeed, PhD University of Khartoum Faculty of Medicine Department of Physiology
Principal Investigator: Lamis AA Kaddam, MSc Department of physiology Faculty of Medicine Alneelain University Khartoum,
PRS Account Al-Neelain University
Verification Date June 2015

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