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Risk of Celiac Disease and Age at Gluten Introduction

NCT00639444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 703

Last updated 2013-12-10

No results posted yet for this study

Summary

The purpose of this study is to determine whether age at introduction of gluten-containing cereals (e.g. wheat) plays a role in influencing the risk of celiac disease (CD) development in infants with a first-degree relative affected by CD.

Conditions

Interventions

DIETARY_SUPPLEMENT

gluten-free, normocaloric diet from 6 to 12 months

Gluten-containing cereals (wheat, rye and barley) will be replaced by gluten-free starchy food (rice, corn, tapioca-based, etc) in a normocaloric diet

Sponsors & Collaborators

  • Associazione Italiana Celiachia (AIC)

    collaborator OTHER

  • Menarini Group

    collaborator INDUSTRY

  • Università Politecnica delle Marche

    lead OTHER

Principal Investigators

  • Carlo Catassi, MD · Università Politecnica delle Marche

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2007-12-31
Completion
2013-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00639444 on ClinicalTrials.gov