NCT02467257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

9 months

First QC Date

June 4, 2015

Last Update Submit

June 5, 2015

Conditions

Sickle Cell Anemia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Intrevention arm

EXPERIMENTAL

Patients received Gum Arabic as intervention

Dietary Supplement: Gum Arabic

Interventions

Gum ArabicDIETARY_SUPPLEMENT

oral ingestion of 30 gram every day for 12 weeks

Intrevention arm

Eligibility Criteria

Age5 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • over 5 year old
  • less t5han 50
  • diagnosed with homozygous sickle cell anemia by Hb electrophoresis

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Hospital

Omdurman, Khartoum State, 1113, Sudan

Location

Related Publications (9)

  • Fathallah H, Atweh GF. Induction of fetal hemoglobin in the treatment of sickle cell disease. Hematology Am Soc Hematol Educ Program. 2006:58-62. doi: 10.1182/asheducation-2006.1.58.

    PMID: 17124041BACKGROUND

  • 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.

    PMID: 23828223BACKGROUND

  • 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. doi: 10.1038/sj.ki.5000028.

    PMID: 16408114BACKGROUND

  • Ballal A, Bobbala D, Qadri SM, Foller 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.

    PMID: 21599958BACKGROUND

  • Kaddam LA, Kaddam AS. Effect of Gum Arabic (Acacia senegal) on C-reactive protein level among sickle cell anemia patients. BMC Res Notes. 2020 Mar 18;13(1):162. doi: 10.1186/s13104-020-05016-2.

    PMID: 32188508DERIVED

  • Kaddam L, Fadl-Elmula I, Eisawi OA, Abdelrazig HA, Saeed AM. Acacia Senegal (Gum Arabic) Supplementation Modulate Lipid Profile and Ameliorated Dyslipidemia among Sickle Cell Anemia Patients. J Lipids. 2019 Jun 18;2019:3129461. doi: 10.1155/2019/3129461. eCollection 2019.

    PMID: 31316836DERIVED

  • Kaddam LA, Fdl-Elmula I, Eisawi OA, Abdelrazig HA, Elnimeiri MK, Saeed AM. Biochemical effects and safety of Gum arabic (Acacia Senegal) supplementation in patients with sickle cell anemia. Blood Res. 2019 Mar;54(1):31-37. doi: 10.5045/br.2019.54.1.31. Epub 2019 Mar 21.

    PMID: 30956961DERIVED

  • Kaddam L, Fadl-Elmula I, Eisawi OA, Abdelrazig HA, Salih MA, Lang F, Saeed AM. Gum Arabic as novel anti-oxidant agent in sickle cell anemia, phase II trial. BMC Hematol. 2017 Mar 16;17:4. doi: 10.1186/s12878-017-0075-y. eCollection 2017.

    PMID: 28331623DERIVED

  • Kaddam L, FdleAlmula I, Eisawi OA, Abdelrazig HA, Elnimeiri M, Lang F, Saeed AM. Gum Arabic as fetal hemoglobin inducing agent in sickle cell anemia; in vivo study. BMC Hematol. 2015 Dec 29;15:19. doi: 10.1186/s12878-015-0040-6. eCollection 2015.

    PMID: 26719803DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Gum Arabic

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • Amal M Saeed, PhD

    University of Khartoum Faculty of Medicine Department of Physiology

    STUDY DIRECTOR

  • Lamis AA Kaddam, MSc

    Department of physiology Faculty of Medicine Alneelain University Khartoum,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 10, 2015

Study Start

April 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

SU(1)