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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

Must not have

Current infection in the last 30 days

Treatment with Zn supplements or multivitamins containing >11 mg of Zn in the last month

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 3 and month 6

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I have celiac disease confirmed by blood tests and a biopsy showing intestinal damage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had an infection in the last 30 days.

Select...

I haven't taken Zn supplements or multivitamins with more than 11 mg of Zn in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3 and month 6

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compliance of Dietary Therapy

Compliance of Supplementation Therapy

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met