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Completed

NCT Number: NCT02467257

Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

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

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Key information

Conditions

Sickle Cell Anemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

5 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Military Hospital

Omdurman, Khartoum State, 1113, Sudan

About this study

: 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Gum Arabic

Dietary Supplement

oral ingestion of 30 gram every day for 12 weeks

Primary outcomes

  1. The primary endpoint of the study will be the level of fetal hemoglobin after three months

    Time frame: 12 weeks

    fetal hemoglobin will be measured each month for three months

Sponsors and collaborators

Lead sponsor

Al-Neelain University

Other

Collaborators

  • Military hospital
  • Ministry of Higher Education and Scientific Research, Republic of Sudan

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2015
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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