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Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

A

Al-Neelain University

Status and phase

Completed
Phase 2
Phase 1

Conditions

Sickle Cell Anemia

Treatments

Dietary Supplement: Gum Arabic

Study type

Interventional

Funder types

Other

Identifiers

NCT02467257
AlNeelainU

Details and patient eligibility

About

The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin inducing agent for sickle cell anemia patients.

Full 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.

Enrollment

47 patients

Sex

All

Ages

5 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

47 participants in 1 patient group

Intrevention arm
Experimental group
Description:
Patients received Gum Arabic as intervention
Treatment:
Dietary Supplement: Gum Arabic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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