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Zinc Treatments for Celiac Disease

N/A
Recruiting
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of CeD based on specific CeD serology (elevated anti-tissue transglutaminase IgA, deaminated gliadin peptides-Immunoglobulin G or anti-endomysial antibodies IgA) and confirmed by duodenal biopsies showing villous atrophy (Marsh 3a or greater)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3 and month 6
Awards & highlights

Study Summary

This trial aims to study the effects of a zinc-optimized gluten-free diet compared to zinc supplementation on celiac patients with zinc deficiency. It will evaluate if it can normalize zinc levels and improve CeD symptoms.

Who is the study for?
This trial is for people with Celiac Disease who have been on a gluten-free diet for over 6 months and have low zinc levels in their blood. They must not be pregnant, breastfeeding, or have had recent infections or serious illnesses that could affect the study.Check my eligibility
What is being tested?
The study compares two ways to treat zinc deficiency in Celiac Disease patients: taking zinc supplements versus eating a diet optimized with enough zinc. It's a randomized controlled trial at McMaster University lasting 6 months.See study design
What are the potential side effects?
Potential side effects from the interventions may include digestive discomfort or allergic reactions to zinc supplements. However, since dietary changes are being tested as well, there might be fewer side effects compared to typical drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have celiac disease confirmed by blood tests and a biopsy showing intestinal damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3 and month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compliance of Dietary Therapy
Compliance of Supplementation Therapy
Secondary outcome measures
Change from Baseline in Celiac Disease Symptoms at Month 3
Change from Baseline in Depression and Anxiety Symptoms at Month 3
Change from Baseline in Extra-Intestinal Symptoms at Month 3
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Zinc Optimized DietExperimental Treatment1 Intervention
Instructions provided by a dietitian to establish a target of 11 mg/day (female) and 14 mg /day (male) provided by Zn-rich food sources, adjusted for dietary phytate intake.
Group II: Zinc SupplementationActive Control1 Intervention
Those allocated in this arm will be provided with 90 capsules of gluten-free Zn gluconate 25 mg (7 mg of elemental Zn; Jamieson®) and will be instructed to take 1 tablet daily with a meal and at least 2 hrs apart from other medications, and iron or copper supplements

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,598,266 Total Patients Enrolled
4 Trials studying Celiac Disease
240 Patients Enrolled for Celiac Disease
Hamilton Health Sciences CorporationOTHER
368 Previous Clinical Trials
300,951 Total Patients Enrolled

Media Library

Zinc Supplementation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05782257 — N/A
Celiac Disease Research Study Groups: Zinc Supplementation, Zinc Optimized Diet
Celiac Disease Clinical Trial 2023: Zinc Supplementation Highlights & Side Effects. Trial Name: NCT05782257 — N/A
Zinc Supplementation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05782257 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in this clinical investigation?

"Affirmative. The clinicaltrials.gov website states that this research study, which was first posted on December 8th 2022, is presently in search of participants. 50 individuals will be sought from a single medical centre."

Answered by AI

Is there still capacity for participation in this investigation?

"As of the most recent update on clinicaltrials.gov, this medical trial is still in need of participants and began recruiting on December 8th 2022. The details have been revised as recently as March 10th 2023."

Answered by AI

What are the expected effects of this experiment?

"The study's primary outcome to be measured over the course of six months is assessing compliance with supplementation therapy. Secondary goals include tracking changes in plasma zinc levels from month 3 to 6, and measuring variations in celiac disease symptoms at both month 3 and 6 using the Celiac Symptoms Index (CSI). This index ranges between 16-80, with higher scores indicating greater severity of symptoms."

Answered by AI

Who else is applying?

What site did they apply to?
McMaster University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet
Maria Ines Pinto Sanchez 2022. "Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05782257.
All > Celiac Disease
~10 spots leftby Sep 2024
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