NCT01704794

Brief Summary

The purpose of this study is to determine the antioxidant effect of prolonged use of sorghum bicolor (jobelyn) to increase the level of plasma superoxide dismutase and glutathione reductase in patients with sickle cell disease and to determine if there is any improvement in the quality of life of the patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 3, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

October 3, 2012

Last Update Submit

April 1, 2013

Conditions

Other Sickle-cell Disorders With Crisis, Unspecified

Keywords

Sickle Cell AnemiaQuality of LifeAntioxidantAnti inflammatorySorghum bicolor

Outcome Measures

Primary Outcomes (1)

  • number of severe bone pain crises and hospital admissions in one year

    Use of health related quality of life measures tool SF-36 and self reporting questionnaires

    12 months

Secondary Outcomes (1)

  • Antioxidant and anti-inflammatory effect

    12 months

Study Arms (3)

Folic Acid + Paludrine +Jobelyn (500mg)

ACTIVE COMPARATOR

Folic acid 5mg given twice daily. Paludrine 50mg to 20mg daily. Jobelyn 500mg once daily.

Dietary Supplement: Folic Acid + Paludrine + Jobelyn (500mg)

Folic Acid + Paludrine +Jobelyn (250mg.)

ACTIVE COMPARATOR

Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 250mg daily

Drug: Folic Acid + Paludrine + Jobelyn (250mg)

Folic Acid + Paludrine + Jobelyn (2mg)

ACTIVE COMPARATOR

Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 2mg daily

Dietary Supplement: Folic Acid + Paludrine + Jobelyn (2mg)

Interventions

Folic Acid + Paludrine + Jobelyn (500mg)DIETARY_SUPPLEMENT

Combination of routine drugs + Jobelyn

Also known as: Routine drugs, Sorghum bicolor extract (Jobelyn 500mg)
Folic Acid + Paludrine +Jobelyn (500mg)
Folic Acid + Paludrine + Jobelyn (250mg)DRUG

Standard routine drugs for treatment of SCD with 250mg Jobelyn

Also known as: Routine drugs, Sorghum bicolor extract (250mg)
Folic Acid + Paludrine +Jobelyn (250mg.)
Folic Acid + Paludrine + Jobelyn (2mg)DIETARY_SUPPLEMENT

Combination of Paludrine + Folic Acid and Jobelyn 2mg (Sorghum bicolor extract)

Also known as: Other Names: Routine drugs, Jobelyn (Sorghum bicolor extract)
Folic Acid + Paludrine + Jobelyn (2mg)

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • AGE : 14 To 40 years
  • SEX: Both sexes
  • Homozygous for the S gene (SS)

You may not qualify if:

  • Age below 14 years and above 40 years
  • Evidence of organ failure i.e heart failure, renal failure
  • No consent for study
  • Poor adherence to treatment and irregular visit to the clinic
  • Presence of chronic inflammation
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lagos State University Teaching Hospital

Ikeja, Lagos, 100001, Nigeria

RECRUITING

Related Publications (19)

  • Brohan M, Jerkovic V, Collin S. Potentiality of red sorghum for producing stilbenoid-enriched beers with high antioxidant activity. J Agric Food Chem. 2011 Apr 27;59(8):4088-94. doi: 10.1021/jf1047755. Epub 2011 Mar 7.

    PMID: 21381750BACKGROUND

  • Geera B, Ojwang LO, Awika JM. New highly stable dimeric 3-deoxyanthocyanidin pigments from sorghum bicolor leaf sheath. J Food Sci. 2012 May;77(5):C566-72. doi: 10.1111/j.1750-3841.2012.02668.x. Epub 2012 Apr 10.

    PMID: 22489620BACKGROUND

  • Kayode AP, Nout MJ, Linnemann AR, Hounhouigan JD, Berghofer E, Siebenhandl-Ehn S. Uncommonly high levels of 3-deoxyanthocyanidins and antioxidant capacity in the leaf sheaths of dye sorghum. J Agric Food Chem. 2011 Feb 23;59(4):1178-84. doi: 10.1021/jf103963t. Epub 2011 Jan 25.

    PMID: 21322653BACKGROUND

  • Yang L, Browning JD, Awika JM. Sorghum 3-deoxyanthocyanins possess strong phase II enzyme inducer activity and cancer cell growth inhibition properties. J Agric Food Chem. 2009 Mar 11;57(5):1797-804. doi: 10.1021/jf8035066.

    PMID: 19256554BACKGROUND

  • Shih CH, Siu SO, Ng R, Wong E, Chiu LC, Chu IK, Lo C. Quantitative analysis of anticancer 3-deoxyanthocyanidins in infected sorghum seedlings. J Agric Food Chem. 2007 Jan 24;55(2):254-9. doi: 10.1021/jf062516t.

    PMID: 17227050BACKGROUND

  • Hunt DM, Emerson SU, Wagner RR. RNA- temperature-sensitive mutants of vesicular stomatitis virus: L-protein thermosensitivity accounts for transcriptase restriction of group I mutants. J Virol. 1976 May;18(2):596-603. doi: 10.1128/JVI.18.2.596-603.1976.

    PMID: 178900BACKGROUND

  • Burdette A, Garner PL, Mayer EP, Hargrove JL, Hartle DK, Greenspan P. Anti-inflammatory activity of select sorghum (Sorghum bicolor) brans. J Med Food. 2010 Aug;13(4):879-87. doi: 10.1089/jmf.2009.0147.

    PMID: 20673059BACKGROUND

  • Park JH, Darvin P, Lim EJ, Joung YH, Hong DY, Park EU, Park SH, Choi SK, Moon ES, Cho BW, Park KD, Lee HK, Kim MJ, Park DS, Chung IM, Yang YM. Hwanggeumchal sorghum induces cell cycle arrest, and suppresses tumor growth and metastasis through Jak2/STAT pathways in breast cancer xenografts. PLoS One. 2012;7(7):e40531. doi: 10.1371/journal.pone.0040531. Epub 2012 Jul 6.

    PMID: 22792362BACKGROUND

  • Wu L, Huang Z, Qin P, Yao Y, Meng X, Zou J, Zhu K, Ren G. Chemical characterization of a procyanidin-rich extract from sorghum bran and its effect on oxidative stress and tumor inhibition in vivo. J Agric Food Chem. 2011 Aug 24;59(16):8609-15. doi: 10.1021/jf2015528. Epub 2011 Jul 29.

    PMID: 21780844BACKGROUND

  • Awika JM, McDonough CM, Rooney LW. Decorticating sorghum to concentrate healthy phytochemicals. J Agric Food Chem. 2005 Aug 10;53(16):6230-4. doi: 10.1021/jf0510384.

    PMID: 16076098BACKGROUND

  • Gee L, Abbott J, Conway SP, Etherington C, Webb AK. Validation of the SF-36 for the assessment of quality of life in adolescents and adults with cystic fibrosis. J Cyst Fibros. 2002 Sep;1(3):137-45. doi: 10.1016/s1569-1993(02)00079-6.

    PMID: 15463820BACKGROUND

  • Okochi,V.I.,Okpuzor J, Okubena M.O., Awoyemi A.K. 2003 . The Influence of African Herbal Formula on the haematological parameters of trypanosome infected rats. African Journal of Biotechnology. 2 (9), 312-316.

    BACKGROUND

  • Erah P,O., Asonye C.C. Okhamafe A.O. 2003. Response of trypanosome brucei brucei induced anaemiato a commercialherbal preparation. African Journal of Biotechnology. 2,9, 307-311.

    BACKGROUND

  • Ogwumike OO. Hemopoietic effect of aqueous extract of the leaf sheath of Sorghum bicolor in albino rats. African Journal of Biomedical. Research. (2002): Vol 5; 69 - 71

    BACKGROUND

  • Oladiji AT, Jacob TO, Yakubu MT. Anti-anaemic potentials of aqueous extract of Sorghum bicolor (L.) moench stem bark in rats. J Ethnopharmacol. 2007 May 22;111(3):651-6. doi: 10.1016/j.jep.2007.01.013. Epub 2007 Jan 18.

    PMID: 17306481BACKGROUND

  • Akande IS, Oseni AA, Biobaku OA. Effects of aqueous extract of Sorghum bicolor on hepatic, histological and haematological indices in rats. Journal of Cell and Animal Biology 4(9), 137-142, 2010.

    BACKGROUND

  • Nwinyi FC, Kwanashie HO. Evaluation of aqueous methanolic extract of Sorghum bicolor leaf base for antinociceptive and anti-inflammatory activities. African Journal of Biotechnology, 8 (18), 4642-4649, 2009.

    BACKGROUND

  • Eniojukan JF, Bolajoko AA. Toxicological Profiles of Commercial Herbal Preperation, Jobelyn. International Journal of Health Research, 2(4), 369-374, 2009.

    BACKGROUND

  • USDA Database for the Oxygen Radical Absorbance Capacity (ORAC) of Selected Foods, Release 2, U.S. Department of Agriculture, 2010.

    BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Folic AcidProguanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • A O Dosunmu, M.D.

    Lagos State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

A O Dosunmu, M.D.

CONTACT

2348023369785doyin_dosunmu@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CONSULTANT IN THE DEPARTMENT OF HAEMATOLOGY & BLOOD TRANSFUSION, LASUTH

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 11, 2012

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

September 1, 2014

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

NG(1)