NCT03365570

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

December 2, 2017

Last Update Submit

January 29, 2019

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 minutes

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 28189173BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Anemia, Iron-DeficiencyOral Manifestations

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMouth DiseasesStomatognathic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fatheya Zahran, Professor

    Head of the Department of Oral Medicine and periodontology Cairo University

    STUDY CHAIR
  • Eman Alsheikh

    Master student

    PRINCIPAL INVESTIGATOR
  • Eman Mo Amr, A.Professor

    associate professor in the Department of Oral Medicine and periodontology Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BDS, Master student at oral medicine department

Study Record Dates

First Submitted

December 2, 2017

First Posted

December 7, 2017

Study Start

May 1, 2018

Primary Completion

November 1, 2018

Study Completion

November 9, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations