Last updated: March 10, 2023
Sponsor: McMaster University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Celiac Disease
Treatment
N/AClinical Study ID
NCT05782257
14999
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of CeD based on specific CeD serology (elevated anti-tissue transglutaminaseIgA, deaminated gliadin peptides-Immunoglobulin G or anti-endomysial antibodies IgA)and confirmed by duodenal biopsies showing villous atrophy (Marsh 3a or greater);
- Adopting a gluten-free diet for at least 6 months;
- Untreated Zn deficiency (Zn plasma levels ≤9.3 µmol/L)
Exclusion
Exclusion Criteria:
- Are already on a Zn optimized diet;
- Treatment with Zn supplements or multivitamins containing >11 mg of Zn in the lastmonth;
- Prior allergic reaction to Zn supplements;
- Treatment with antibiotics or probiotics supplements in the last 30 days;
- Pregnancy or lactation
- Current infection in the last 30 days;
- Intestinal obstruction, short gut (remnant bowel <180 cm), or any serious illnessconsidered by the investigator that will interfere with the study procedure orresults. Data including medication and supplementation will be recorded in case reportform and Zn content added to total Zn in the analysis.
- Untreated pancreatic insufficiency (fecal elastase <200).
Study Design
Total Participants: 50
Study Start date:
December 08, 2022
Estimated Completion Date:
September 01, 2024
Connect with a study center
McMaster University
Hamilton,
CanadaActive - Recruiting
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