Iron Deficiency AnemiaNCT03365570
Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population
An observational study of Iron Deficiency Anemia, run by Cairo University at 1 site in Egypt.
Trial summary
According to WHO Reportin 2002, iron deficiency anemia was considered to be the most important contributing factor to the global burden of anemia. Children and women in reproductive ages are more at risk factor for developing iron deficiency anemia.No previous study has been held to assess prevalence of oral… Read more about this study
- Who is it for?
- Ages Up to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 9 Nov 2018
- Phase
- Observational
- 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 Up to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants: Egyptian patients diagnosed with Iron deficiency anemia that attending the Hematology department at El Qasr Al-Einy Cairo University Hospital will be enrolled in the study. The age of participant enroll will be up to 70 years old, males and females will be included. For each eligible participant, a full history will be obtained according to an assessment sheet, followed by clinical examination which will be done through an interview between the investigator and the patient. All participants will be asked to sign a study-related informed consent.
Who may be able to join
- Patients diagnosed with iron deficiency anemia based on their blood tests.
- Age: by maximum 70 years old.
- Males and females will be included.
Who cannot join
- Patients suffering from any other systemic diseases known to influence oral and maxillofacial manifestations will be excluded.
- Patients suffering from any other systemic diseases known to cause IDA as secondary condition will be excluded.
- Patients on drug therapy that may have oral mucosal manifestations.
- Lesions appear because of existing local factors for example traumatic ulcer on the tongue because of sharp tooth against tongue, angular cheilitis because of poor denture design and older age patients.
- Inflammatory diseases, malignancy, or recent surgery were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population, Hospital-based Cross-sectional Study
According to WHO Reportin 2002, iron deficiency anemia was considered to be the most important contributing factor to the global burden of anemia. Children and women in reproductive ages are more at risk factor for developing iron deficiency anemia.No previous study has been held to assess prevalence of oral manifestations of iron deficiency anemia as a hospital-based cross-sectional study on a sample of Egyptian patients in hematology department (no previous data recorded).
Read the detailed description
Study will be held in at the Hematology department at El Qasr Al-Einy Cairo University Hospital data collection started from February 2018 till end of April 2018 primary completion.
Clinical examination performed for oral mucosa, the number and type of lesions will be recorded. Patients' age, sex, duration of illness, type of anemia, location of any oral lesion or abnormality, history of drug and alcohol consumption, and presence or absence of dentures, will be recorded participants will not followed up and data will be collected prospectively.
A copy of participant's blood record will be obtained from the hematology department upon its approval.
Participants:
Egyptian patients diagnosed with Iron deficiency anemia that attending the Hematology department at El Qasr Al-Einy Cairo University Hospital will be enrolled in the study. The age of participant enroll will be up to 70 years old, males and females will be included.
For each eligible participant, a full history will be obtained according to an assessment sheet, followed by clinical examination which will be done through an interview between the investigator and the patient.
All participants will be asked to sign a study-related informed consent. Oral manifestations of these patients will be evaluated by an oral medicine master student (the investigator).
- Conditions
- Iron Deficiency Anemia
- Keywords
- hemoglobin, iron, oral lesions, oral manifestations,cross-sectional study
- Medical subject headings
- Anemia, Iron-Deficiency, Oral Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of oral mucosal lesions
Presence of oral mucosal lesions will be assessed by clinical picture into dichotomous outcome (Yes/No) and percentage of each.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 May 2018
- Primary completion1 Nov 2018
- Study completion9 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed Abdallah Alsheikh, Cairo University
- Investigators
- Fatheya Zahran, Professor, Study chair, Head of the Department of Oral Medicine and periodontology Cairo UniversityEman Alsheikh, Principal investigator, Master studentEman Mo Amr, A.Professor, Study director, associate professor in the Department of Oral Medicine and periodontology Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365570
- Sponsor's protocol ID
- oral lesions and anemia
- Status last verified
- Jan 2019
- First submitted
- 2 Dec 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
DeLoughery TG. Iron Deficiency Anemia. Med Clin North Am. 2017 Mar;101(2):319-332. doi: 10.1016/j.mcna.2016.09.004. Epub 2016 Dec 8.
PubMed 28189173Rohani B. Oral manifestations and blood profile in patients with iron deficiency anemia. J Formos Med Assoc. 2015 Jan;114(1):97. doi: 10.1016/j.jfma.2014.07.004. Epub 2014 Aug 10. No abstract available.
PubMed 25115528Wu YC, Wang YP, Chang JY, Cheng SJ, Chen HM, Sun A. Oral manifestations and blood profile in patients with iron deficiency anemia. J Formos Med Assoc. 2014 Feb;113(2):83-7. doi: 10.1016/j.jfma.2013.11.010. Epub 2013 Dec 30.
PubMed 24388269
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population, Hospital-based Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03365570
- Acronym / sponsor ID
- oral lesions and anemia
- Conditions
- Iron Deficiency Anemia
- Keywords
- hemoglobin, iron, oral lesions, oral manifestations,cross-sectional study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 7 Dec 2017 (actual)
- 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.
According to WHO Reportin 2002, iron deficiency anemia was considered to be the most important contributing factor to the global burden of anemia. Children and women in reproductive ages are more at risk factor for developing iron deficiency anemia.No previous study has been held to assess prevalence of oral manifestations of iron deficiency anemia as a hospital-based cross-sectional study on a sample of Egyptian patients in hematology department (no previous data recorded).
Detailed description
Study will be held in at the Hematology department at El Qasr Al-Einy Cairo University Hospital data collection started from February 2018 till end of April 2018 primary completion.
Clinical examination performed for oral mucosa, the number and type of lesions will be recorded. Patients' age, sex, duration of illness, type of anemia, location of any oral lesion or abnormality, history of drug and alcohol consumption, and presence or absence of dentures, will be recorded participants will not followed up and data will be collected prospectively.
A copy of participant's blood record will be obtained from the hematology department upon its approval.
Participants:
Egyptian patients diagnosed with Iron deficiency anemia that attending the Hematology department at El Qasr Al-Einy Cairo University Hospital will be enrolled in the study. The age of participant enroll will be up to 70 years old, males and females will be included.
For each eligible participant, a full history will be obtained according to an assessment sheet, followed by clinical examination which will be done through an interview between the investigator and the patient.
All participants will be asked to sign a study-related informed consent. Oral manifestations of these patients will be evaluated by an oral medicine master student (the investigator).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants: Egyptian patients diagnosed with Iron deficiency anemia that attending the Hematology department at El Qasr Al-Einy Cairo University Hospital will be enrolled in the study. The age of participant enroll will be up to 70 years old, males and females will be included. For each eligible participant, a full history will be obtained according to an assessment sheet, followed by clinical examination which will be done through an interview between the investigator and the patient. All participants will be asked to sign a study-related informed consent.
Key inclusion criteria (3 listed)
- Patients diagnosed with iron deficiency anemia based on their blood tests.
- Age: by maximum 70 years old.
- Males and females will be included.
Key exclusion criteria (5 listed)
- Patients suffering from any other systemic diseases known to influence oral and maxillofacial manifestations will be excluded.
- Patients suffering from any other systemic diseases known to cause IDA as secondary condition will be excluded.
- Patients on drug therapy that may have oral mucosal manifestations.
- Lesions appear because of existing local factors for example traumatic ulcer on the tongue because of sharp tooth against tongue, angular cheilitis because of poor denture design and older age patients.
- Inflammatory diseases, malignancy, or recent surgery were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of oral mucosal lesions
Time frame: 15 minutes
Presence of oral mucosal lesions will be assessed by clinical picture into dichotomous outcome (Yes/No) and percentage of each.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Background: PubMed 28189173DeLoughery TG. Iron Deficiency Anemia. Med Clin North Am. 2017 Mar;101(2):319-332. doi: 10.1016/j.mcna.2016.09.004. Epub 2016 Dec 8.
- Results publication: PubMed 25115528Rohani B. Oral manifestations and blood profile in patients with iron deficiency anemia. J Formos Med Assoc. 2015 Jan;114(1):97. doi: 10.1016/j.jfma.2014.07.004. Epub 2014 Aug 10. No abstract available.
- Results publication: PubMed 24388269Wu YC, Wang YP, Chang JY, Cheng SJ, Chen HM, Sun A. Oral manifestations and blood profile in patients with iron deficiency anemia. J Formos Med Assoc. 2014 Feb;113(2):83-7. doi: 10.1016/j.jfma.2013.11.010. Epub 2013 Dec 30.
- Individual participant dataSharing planned: No
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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.
Fatheya Zahran, Professor study chair
Head of the Department of Oral Medicine and periodontology Cairo University
Eman Alsheikh principal investigator
Master student
Eman Mo Amr, A.Professor study director
associate professor in the Department of Oral Medicine and periodontology Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia, run by Cairo University at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 30 Jan 2019. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of oral mucosal lesions (time frame: 15 minutes). 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 NCT03365570, which also lists 3 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 30 Jan 2019.