Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

Phase 1

Completed

• Conditions: Sickle Cell Anemia
• Interventions: Dietary Supplement: Gum Arabic

• Registration Number: NCT02467257
• Lead Sponsor: Al-Neelain University

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 Timeline

• Study Start: 2014-04
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-06
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-05
• Last Update Submitted: 2015-06-05
• Study First Posted: 2015-06-10
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrevention arm	Gum Arabic	Patients received Gum Arabic as intervention

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study will be the level of fetal hemoglobin after three months	12 weeks	fetal hemoglobin will be measured each month for three months

Trial Locations

Locations (1)

Military Hospital; 🇸🇩 Omdurman, Khartoum, Sudan