Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population

• ClinicalTrials.gov Identifier: NCT03365570
• Recruitment Status: Completed
• First Posted: December 7, 2017
• Last Update Posted: January 30, 2019
• Sponsor: Cairo University
• Information provided by (Responsible Party): Eman Mohamed Abdallah Alsheikh, Cairo University

Study Description

Brief 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 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).

Condition or disease
Iron Deficiency Anemia

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

• Study Type: Observational
• Actual Enrollment: 180 participants
• Observational Model: Ecologic or Community
• Time Perspective: Cross-Sectional
• Official Title: Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population, Hospital-based Cross-sectional Study
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: November 1, 2018
• Actual Study Completion Date: November 9, 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: up to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

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.

Criteria

Inclusion Criteria

1. Patients diagnosed with iron deficiency anemia based on their blood tests.
2. Age: by maximum 70 years old.
3. Males and females will be included.

Exclusion Criteria

1. Patients suffering from any other systemic diseases known to influence oral and maxillofacial manifestations will be excluded.
2. Patients suffering from any other systemic diseases known to cause IDA as secondary condition will be excluded.
3. Patients on drug therapy that may have oral mucosal manifestations.
4. 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.
5. Inflammatory diseases, malignancy, or recent surgery were excluded.

Contacts and Locations

Locations

Egypt

Cairo University

Cairo, Egypt, 12613

Sponsors and Collaborators

Cairo University

Investigators

• Study Chair: Fatheya Zahran, Professor; Head of the Department of Oral Medicine and periodontology Cairo University
• Principal Investigator: Eman Alsheikh; Master student
• Study Director: Eman Mo Amr, A.Professor; associate professor in the Department of Oral Medicine and periodontology Cairo University

More Information

Publications of Results:

Rohani 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.

Wu 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.

Other 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. Review.

• Responsible Party: Eman Mohamed Abdallah Alsheikh, BDS, Master student at oral medicine department, Cairo University
• ClinicalTrials.gov Identifier: NCT03365570
• Other Study ID Numbers: oral lesions and anemia
• First Posted: December 7, 2017
• Last Update Posted: January 30, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Eman Mohamed Abdallah Alsheikh, Cairo University:

hemoglobin, iron, oral lesions, oral manifestations,cross-sectional study

Additional relevant MeSH terms:

Oral Manifestations; Anemia; Anemia, Iron-Deficiency; Deficiency Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases; Malnutrition; Nutrition Disorders; Mouth Diseases; Stomatognathic Diseases