Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

Sickle Cell Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467257
• Other study ID #: AlNeelainU
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 4, 2015
• Last updated: June 5, 2015
• Start date: April 2014
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Al-Neelain University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Sickle Cell Anemia

Intervention

Dietary Supplement:
• Gum Arabic
oral ingestion of 30 gram every day for 12 weeks

Locations

Country	Name	City	State
Sudan	Military Hospital	Omdurman	Khartoum

Sponsors (3)

Lead Sponsor	Collaborator
Al-Neelain University	Military hospital, Ministry of Higher Education and Scientific Research, Republic of Sudan

Country where clinical trial is conducted

Sudan, 

References & Publications (4)

Ballal A, Bobbala D, Qadri SM, Föller M, Kempe D, Nasir O, Saeed A, Lang F. Anti-malarial effect of gum arabic. Malar J. 2011 May 20;10:139. doi: 10.1186/1475-2875-10-139. — View Citation

Fathallah H, Atweh GF. Induction of fetal hemoglobin in the treatment of sickle cell disease. Hematology Am Soc Hematol Educ Program. 2006:58-62. Review. — View Citation

Kutlar A, Reid ME, Inati A, Taher AT, Abboud MR, El-Beshlawy A, Buchanan GR, Smith H, Ataga KI, Perrine SP, Ghalie RG. A dose-escalation phase IIa study of 2,2-dimethylbutyrate (HQK-1001), an oral fetal globin inducer, in sickle cell disease. Am J Hematol. 2013 Nov;88(11):E255-60. doi: 10.1002/ajh.23533. Epub 2013 Oct 3. — View Citation

Matsumoto N, Riley S, Fraser D, Al-Assaf S, Ishimura E, Wolever T, Phillips GO, Phillips AO. Butyrate modulates TGF-beta1 generation and function: potential renal benefit for Acacia(sen) SUPERGUM (gum arabic)? Kidney Int. 2006 Jan;69(2):257-65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of the study will be the level of fetal hemoglobin after three months	fetal hemoglobin will be measured each month for three months	12 weeks