NCT03161899

Brief Summary

Thalassemia is a blood disorder passed down through families in which the body makes an abnormal form of hemoglobin. There are 2 main types of thalassemia; Alpha \& Beta thalassemia. Alpha thalassemia: occurs when a gene or genes related to the alpha globin protein are missing or mutated. Beta-thalassemia syndromes are a group of hereditary blood disorders characterized by reduced or absent beta globin chain synthesis. Beta-thalassemias can be classified into: Silent carrier: completely asymptomatic with normal hematological parameters. Beta-thalassaemia minor (beta-thalassaemia trait): usually asymptomatic; diagnosis is made during a work-up for mild anemia. Beta-thalassaemia intermedia: usually a similar presentation to beta-thalassaemia major; symptoms are usually less pronounced and the course is usually more insidious. Beta-thalassaemia major : In which there is complete absence of hemoglobin A

Trial Health

87
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

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

May 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

May 19, 2017

Last Update Submit

July 28, 2020

Conditions

Keywords

thalassemia - nutrition -growth

Outcome Measures

Primary Outcomes (1)

  • percentage of malnutrition

    prevalence of malnutrition among thalassemic children attending assiut university children hospital

    12 month

Secondary Outcomes (2)

  • aetiology poor growth

    12 month

  • decrease morbidity

    18 month

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

all beta thalassemic patients attending the children Hematology Clinic, Children Hospital, Assiut University, during the period of 1st of June 2017 till 31 th of may 2018.

You may qualify if:

  • patients diagnosed to have thalassemia

You may not qualify if:

  • patient with any underlaying systemic diseases other than B thalassemia major.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asmaa Refaat Abdelmonem

Asyut, Egypt

Location

Related Publications (3)

  • Soliman AT, El-Matary W, Fattah MM, Nasr IS, El Alaily RK, Thabet MA. The effect of high-calorie diet on nutritional parameters of children with beta-thalassaemia major. Clin Nutr. 2004 Oct;23(5):1153-8. doi: 10.1016/j.clnu.2004.03.001.

    PMID: 15380908BACKGROUND
  • Fung EB. Nutritional deficiencies in patients with thalassemia. Ann N Y Acad Sci. 2010 Aug;1202:188-96. doi: 10.1111/j.1749-6632.2010.05578.x.

    PMID: 20712792BACKGROUND
  • Galanello R, Origa R. Beta-thalassemia. Orphanet J Rare Dis. 2010 May 21;5:11. doi: 10.1186/1750-1172-5-11.

    PMID: 20492708BACKGROUND

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • asmaa refaat, MBBCH

    Assuit , faculty of medicine, egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor of pediatrics

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 22, 2017

Study Start

December 15, 2018

Primary Completion

May 24, 2020

Study Completion

July 20, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations