Clinical trial NCT03365570: Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population
Official title: Prevalence of Oral Manifestations of Iron Deficiency Anemia in a Sample of Egyptian Population, Hospital-based Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency Anemia
Keywords: hemoglobin, iron, oral lesions, oral manifestations,cross-sectional study
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 180
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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).

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).

Eligibility 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.

Primary outcomes:
measure: Prevalence of oral mucosal lesions
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of the Department of Oral Medicine and periodontology Cairo University
name: Fatheya Zahran, Professor
role: STUDY_CHAIR
affiliation: Master student
name: Eman Alsheikh
role: PRINCIPAL_INVESTIGATOR
affiliation: associate professor in the Department of Oral Medicine and periodontology Cairo University
name: Eman Mo Amr, A.Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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. No abstract available.
citation: 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.