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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Dietary Supplement: Gum Arabic Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Potential Role of Gum Arabic as Fetal Hemoglobin Agent in Sudanese Sickle Cell Anemia Patients
Study Start Date : April 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intrevention arm
Patients received Gum Arabic as intervention
 Dietary Supplement: Gum Arabic
oral ingestion of 30 gram every day for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467257


Locations
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Sudan
Military Hospital
Omdurman, Khartoum, Sudan, 1113
Sponsors and Collaborators
Al-Neelain University
Military hospital
Ministry of Higher Education and Scientific Research, Republic of Sudan
Investigators
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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,
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lamis Kaddam, Dr, Al-Neelain University
ClinicalTrials.gov Identifier: NCT02467257    
Other Study ID Numbers: AlNeelainU
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn