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Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

Potential Role of Gum Arabic as Fetal Hemoglobin Agent in Sudanese Sickle Cell Anemia Patients

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02467257
Enrollment
47
Registered
2015-06-10
Start date
2014-04-30
Completion date
2015-01-31
Last updated
2015-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Anemia

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.

Interventions

DIETARY_SUPPLEMENTGum Arabic

oral ingestion of 30 gram every day for 12 weeks

Sponsors

Military hospital
CollaboratorUNKNOWN
Ministry of Higher Education and Scientific Research, Republic of Sudan
CollaboratorOTHER_GOV
Al-Neelain University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The primary endpoint of the study will be the level of fetal hemoglobin after three months12 weeksfetal hemoglobin will be measured each month for three months

Countries

Sudan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026