NCT02498340

Brief Summary

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is prevalent and add a burden on families in Egypt and Middle East due to lifelong diet restriction, non-fava beans diet is main food for most families in the region and parents and doctors consider it as a prohibited food whatever the genetic or clinical phenotypes. The effective management is avoiding a spectrum of food and drugs causing oxidative stress. No data is available about the hazards of consumption of non-fava beans diet.

Trial Health

55
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

July 10, 2015

Last Update Submit

July 14, 2015

Conditions

Glucose-6-Phosphate Dehydrogenase Deficiency

Keywords

G6PDgenotypephenotypediet restriction

Outcome Measures

Primary Outcomes (1)

  • Diet challenge

    one year

Study Arms (1)

Diet challenge

EXPERIMENTAL

The patients will have a single blood test after dietetic challenge, they will be subjected to eat non- fava beans diet at doses of 10 -30 gm of 3 different types of non- fava beans( each one will be given once daily for 3 days).

Dietary Supplement: non- fava beans

Interventions

non- fava beansDIETARY_SUPPLEMENT

Patients will be subjected to eat non- fava beans diet at doses of 10 -30 gm (small to moderate amount) of 3 different types of non- fava beans, each one will be given once daily for 3 days.

Diet challenge

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All children with proved enzymatic deficiency of G6PD.
  • Patients who met the criteria of hemoglobin level at study time ≥ 11 gm/dl

You may not qualify if:

  • patients with another enzyme deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hematology clinic, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Glucosephosphate Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Amira Adly, ass. prof

CONTACT

0105245837amiradiabetes@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 10, 2015

First Posted

July 15, 2015

Study Start

December 1, 2015

Primary Completion

July 1, 2016

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations

EG(1)