Other Sickle-cell Disorders With Crisis, UnspecifiedPhase 1/2NCT01704794
Quality of Life Study for Sickle Cell Patients Treated With Jobelyn (Sorghum Bicolor Extract)
A Phase 1/2 study testing Folic Acid + Paludrine + Jobelyn (500mg), Folic Acid + Paludrine + Jobelyn (250mg) and Folic Acid + Paludrine + Jobelyn (2mg) in people with Other Sickle-cell Disorders With Crisis, Unspecified, run by Lagos State University at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Other Sickle-cell Disorders With Crisis, Unspecified
- What is being tested?
- Folic Acid + Paludrine + Jobelyn (500mg), Folic Acid + Paludrine + Jobelyn (250mg) and Folic Acid + Paludrine + Jobelyn (2mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNigeria
- Study dates
- Apr 2013to Sep 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- AGE : 14 To 40 years
- SEX: Both sexes
- Homozygous for the S gene (SS)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
Lagos State University Teaching Hospital
Ikeja, Lagos, 100001
A O Dosunmu, M.D., 2348023369785, doyin_dosunmu@yahoo.com
A O Dosunmu, M.D.
About this study
Official title: Antioxidant Effect of the Extract of Jobelyn (Sorghum Bicolor) on the Quality of Life of Patients With Sickle Cell Disease
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.
Read the detailed description
Jobelyn is an extract of sorghum bicolor that is popular in Nigeria as a herbal food supplement. This extract has been shown to have a high oxygen radical absorbance capacity (ORAC 37,622micro mole TE/g) compared to other botanical preparations 1. A second proven property is its anti inflammatory effect with a selective COX 2 inhibition 2. It has also been shown to correct anaemia induced in experimental rabbit by trypanosome brucei brucei 3.
Jobelyn is being consumed as a herbal nutritional supplement in many disorders including sickle cell disease in Nigeria without complaint in over 15 years. The toxicology profile is impressive with a wide therapeutic range.
Nigeria is one of the countries with the largest burden of sickle cell disease. It is a chronic genetic disorder that accounts for absenteeism at school and at work place. There is also a significant shortening of the life span of the affected patients. Sickle cell anaemia presents with recurrent bone pains and progressive organ damage that affects negatively the quality of life of the patients. Available measures that have been in use include use of hydroxyurea, chronic and acute red cell transfusion and haematopoietic stem cell transplantation. These have limitations in terms of adverse effects, cost and availability.
The pathogenesis involves intracellular precipitation of the mutant haemoglobin, rigidity of the cell, adhesion of cells to the endothelium. These cause recurrent tissue hypoxia and reperfusion which cause release of reactive oxygen series and agents of inflammation. The extract of sorghum is therefore expected to improve the quality of life of these patients.
Previous work done, have not investigated the long time effect of the extract on the quality of life of sickle cell patients. This study is therefore designed to compare the quality of life of patients on 500mg daily, 250mg daily and 2mg daily of jobelyn using adjusted standard tools. The secondary outcomes to study are changes in indicators of inflammation and systemic antioxidants in these patients. The study period is 12 months so that the period shall involve all the weather conditions in the region.
- Being tested
- Folic Acid + Paludrine + Jobelyn (500mg), Folic Acid + Paludrine + Jobelyn (250mg), Folic Acid + Paludrine + Jobelyn (2mg)
- Keywords
- Sickle Cell Anemia, Quality of Life, Antioxidant, Anti inflammatory, Sorghum bicolor
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic Acid + Paludrine + Jobelyn (500mg)Dietary supplement
Also called Routine drugs, Sorghum bicolor extract (Jobelyn 500mg)
Combination of routine drugs + Jobelyn
Folic Acid + Paludrine + Jobelyn (250mg)Drug
Also called Routine drugs, Sorghum bicolor extract (250mg)
Standard routine drugs for treatment of SCD with 250mg Jobelyn
Folic Acid + Paludrine + Jobelyn (2mg)Dietary supplement
Also called Other Names: Routine drugs, Jobelyn (Sorghum bicolor extract)
Combination of Paludrine + Folic Acid and Jobelyn 2mg (Sorghum bicolor extract)
| Study group | Role | What they receive |
|---|---|---|
| Folic Acid + Paludrine +Jobelyn (500mg) | Active comparator | Folic acid 5mg given twice daily. Paludrine 50mg to 20mg daily. Jobelyn 500mg once daily. Receives: 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 Receives: Drug: Folic Acid + Paludrine + Jobelyn (250mg) |
| Folic Acid + Paludrine + Jobelyn (2mg) | Active comparator | Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 2mg daily Receives: Dietary Supplement: Folic Acid + Paludrine + Jobelyn (2mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Antioxidant and anti-inflammatory effect
Increase in glutathion reductase, Increase in superoxide dismutase, Reduction in C reactive protein, Reduction in lactate dehydrogenase and Liver enzymes tests
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Other Sickle-cell Disorders With Crisis, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lagos State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. A. O. Dosunmu, Lagos State University
- Investigators
- A O Dosunmu, M.D., Principal investigator, Lagos State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704794
- Sponsor's protocol ID
- LASUTH/SCD01/2012
- Status last verified
- Apr 2013
- First submitted
- 3 Oct 2012
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21381750Geera 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.
PubMed 22489620Kayode 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.
PubMed 21322653Yang 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.
PubMed 19256554Shih 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.
PubMed 17227050Hunt 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.
PubMed 178900Burdette 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.
PubMed 20673059Park 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.
PubMed 22792362Wu 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.
PubMed 21780844Awika 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.
PubMed 16076098Gee 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.
PubMed 15463820Okochi,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.
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.
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
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.
PubMed 17306481
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant Effect of the Extract of Jobelyn (Sorghum Bicolor) on the Quality of Life of Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT01704794
- Acronym / sponsor ID
- LASUTH/SCD01/2012
- Keywords
- Sickle Cell Anemia, Quality of Life, Antioxidant, Anti inflammatory, Sorghum bicolor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Lagos State UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Jobelyn is an extract of sorghum bicolor that is popular in Nigeria as a herbal food supplement. This extract has been shown to have a high oxygen radical absorbance capacity (ORAC 37,622micro mole TE/g) compared to other botanical preparations 1. A second proven property is its anti inflammatory effect with a selective COX 2 inhibition 2. It has also been shown to correct anaemia induced in experimental rabbit by trypanosome brucei brucei 3.
Jobelyn is being consumed as a herbal nutritional supplement in many disorders including sickle cell disease in Nigeria without complaint in over 15 years. The toxicology profile is impressive with a wide therapeutic range.
Nigeria is one of the countries with the largest burden of sickle cell disease. It is a chronic genetic disorder that accounts for absenteeism at school and at work place. There is also a significant shortening of the life span of the affected patients. Sickle cell anaemia presents with recurrent bone pains and progressive organ damage that affects negatively the quality of life of the patients. Available measures that have been in use include use of hydroxyurea, chronic and acute red cell transfusion and haematopoietic stem cell transplantation. These have limitations in terms of adverse effects, cost and availability.
The pathogenesis involves intracellular precipitation of the mutant haemoglobin, rigidity of the cell, adhesion of cells to the endothelium. These cause recurrent tissue hypoxia and reperfusion which cause release of reactive oxygen series and agents of inflammation. The extract of sorghum is therefore expected to improve the quality of life of these patients.
Previous work done, have not investigated the long time effect of the extract on the quality of life of sickle cell patients. This study is therefore designed to compare the quality of life of patients on 500mg daily, 250mg daily and 2mg daily of jobelyn using adjusted standard tools. The secondary outcomes to study are changes in indicators of inflammation and systemic antioxidants in these patients. The study period is 12 months so that the period shall involve all the weather conditions in the region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Folic Acid + Paludrine +Jobelyn (500mg) | Active comparator | Dietary Supplement: Folic Acid + Paludrine + Jobelyn (500mg)Folic acid 5mg given twice daily. Paludrine 50mg to 20mg daily. Jobelyn 500mg once daily. |
| Folic Acid + Paludrine +Jobelyn (250mg.) | Active comparator | Drug: Folic Acid + Paludrine + Jobelyn (250mg)Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 250mg daily |
| Folic Acid + Paludrine + Jobelyn (2mg) | Active comparator | Dietary Supplement: Folic Acid + Paludrine + Jobelyn (2mg)Folic Acid 5mg daily Paludrine 20 - 40mg daily Jobelyn 2mg daily |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- AGE : 14 To 40 years
- SEX: Both sexes
- Homozygous for the S gene (SS)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic Acid + Paludrine + Jobelyn (500mg)Also: Routine drugs, Sorghum bicolor extract (Jobelyn 500mg)Combination of routine drugs + Jobelyn | Dietary supplement | Folic Acid + Paludrine +Jobelyn (500mg) |
| Folic Acid + Paludrine + Jobelyn (250mg)Also: Routine drugs, Sorghum bicolor extract (250mg)Standard routine drugs for treatment of SCD with 250mg Jobelyn | Drug | Folic Acid + Paludrine +Jobelyn (250mg.) |
| Folic Acid + Paludrine + Jobelyn (2mg)Also: Other Names: Routine drugs, Jobelyn (Sorghum bicolor extract)Combination of Paludrine + Folic Acid and Jobelyn 2mg (Sorghum bicolor extract) | Dietary supplement | Folic Acid + Paludrine + Jobelyn (2mg) |
Primary outcome
number of severe bone pain crises and hospital admissions in one year
Time frame: 12 months
Use of health related quality of life measures tool SF-36 and self reporting questionnaires
1 secondary outcome
Antioxidant and anti-inflammatory effect
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Background: PubMed 21381750Brohan 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.
- Background: PubMed 22489620Geera 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.
- Background: PubMed 21322653Kayode 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.
- Background: PubMed 19256554Yang 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.
- Background: PubMed 17227050Shih 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.
- Background: PubMed 178900Hunt 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.
- Background: PubMed 20673059Burdette 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.
- Background: PubMed 22792362Park 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.
- Background: PubMed 21780844Wu 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.
- Background: PubMed 16076098Awika 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.
- Background: PubMed 15463820Gee 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.
- BackgroundOkochi,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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A O Dosunmu, M.D. principal investigator
Lagos State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Folic Acid + Paludrine + Jobelyn (500mg), Folic Acid + Paludrine + Jobelyn (250mg) and Folic Acid + Paludrine + Jobelyn (2mg) in people with Other Sickle-cell Disorders With Crisis, Unspecified, run by Lagos State University at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact A O Dosunmu, M.D. (2348023369785, doyin_dosunmu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of severe bone pain crises and hospital admissions in one year (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01704794, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.