- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05782257
Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet
A Pilot Study to Evaluate the Feasibility of a Zinc-optimized Gluten-free Diet Compared With Supplements to Treat Zinc Deficiency in Celiac Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hamilton, Canada
- Recruiting
- McMaster University
-
Contact:
- Shilpa Tandon, BSc
- Phone Number: 21875 9055212100
- Email: tandos1@mcmaster.ca
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Principal Investigator:
- Maria Ines Pinto-Sanchez, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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);
- Adopting a gluten-free diet for at least 6 months;
- Untreated Zn deficiency (Zn plasma levels ≤9.3 µmol/L)
Exclusion Criteria:
- Are already on a Zn optimized diet;
- Treatment with Zn supplements or multivitamins containing >11 mg of Zn in the last month;
- 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 illness considered by the investigator that will interfere with the study procedure or results. Data including medication and supplementation will be recorded in case report form and Zn content added to total Zn in the analysis.
- Untreated pancreatic insufficiency (fecal elastase <200).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Zinc Supplementation
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
|
Take one 25mg Zn gluconate tablet daily
|
Experimental: Zinc Optimized Diet
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.
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Consume 11 mg/day of zinc-rich foods for females and 14 mg/day in males.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance of Dietary Therapy
Time Frame: 6 months
|
To assess compliance to a zinc-optimized dietary treatment.
Dietary compliance is measured through evaluating zinc levels from biweekly participant food diaries.
|
6 months
|
Compliance of Supplementation Therapy
Time Frame: 6 months
|
To assess compliance to zinc supplementation therapy.
Supplementation compliance is measured by pill counting.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Zinc Plasma Levels at Month 3
Time Frame: Baseline and Month 3
|
Plasma Zinc will be measured through bloodwork.
Normal plasma zinc (pZn) levels: 9.4 ≤ pZn ≤ 15 ug/dL.
Change = (Month 3 - Baseline)
|
Baseline and Month 3
|
Change in Zinc Plasma Levels from Month 3 to Month 6
Time Frame: Month 3 and Month 6
|
Plasma Zinc will be measured through bloodwork.
Normal plasma zinc (pZn) levels: 9.4 ≤ pZn ≤ 15 ug/dL.
Change = (Month 6- Month 3)
|
Month 3 and Month 6
|
Change from Baseline in Celiac Disease Symptoms at Month 3
Time Frame: Baseline and Month 3
|
The Celiac Symptoms Index (CSI) is a validated disease-specific symptom index in adults with celiac disease.
Possible total scores range from 16 (no symptoms) to 80 (worst possible symptoms).
Higher scores indicate increase in severity of symptoms.
Change = (Month 3 - baseline)
|
Baseline and Month 3
|
Change in Celiac Disease Symptoms from Month 3 to Month 6
Time Frame: Month 3 and Month 6
|
The Celiac Symptoms Index (CSI) is a validated disease-specific symptom index in adults with celiac disease.
Higher scores indicate increase in severity of symptoms.
Possible total scores range from 16 (no symptoms) to 80 (worst possible symptoms).
Change = (Month 6 - Month 3)
|
Month 3 and Month 6
|
Change from Baseline in Extra-Intestinal Symptoms at Month 3
Time Frame: Baseline and Month 3
|
The Visual Analog Scale (VAS) is a validated subjective measure of acute and chronic pain. Possible total scores range from 0 (no symptoms) to 100 (very severe symptoms). Higher scores indicate increase in severity of symptoms. Change = (Month 3 - Baseline). |
Baseline and Month 3
|
Change in Extra-Intestinal Symptoms from Month 3 to Month 6
Time Frame: Month 3 and Month 6
|
The Visual Analog Scale (VAS) is a validated subjective measure of acute and chronic pain. Possible total scores range from 0 (no symptoms) to 100 (very severe symptoms). Higher scores indicate increase in severity of depression and anxiety. Change = (Month 6 - Month 3). |
Month 3 and Month 6
|
Change from Baseline in Depression and Anxiety Symptoms at Month 3
Time Frame: Baseline and Month 3
|
The Hospital Anxiety and Depression Scale (HADS) is a questionnaire assessing patient anxiety and depression.
Possible scores range from 0 (normal) to 21 (abnormal).
Higher scores indicate increase in severity of depression and anxiety.
Change = (Month 3- Baseline).
|
Baseline and Month 3
|
Change in Depression and Anxiety Symptoms from Month 3 to Month 6
Time Frame: Month 3 and Month 6
|
The Hospital Anxiety and Depression Scale (HADS) is a questionnaire assessing patient anxiety and depression.
Possible scores range from 0 (normal) to 21 (abnormal).
Higher scores indicate increase in severity of depression and anxiety.
Change = (Month 6- Month 3).
|
Month 3 and Month 6
|
Change from Baseline in Intestinal Function at Month 3
Time Frame: Baseline and Month 3
|
Intestinal function/mass is measured by citrulline plasma levels.
Normal citrulline levels range from 20-50 umol/L.
Higher levels indicate increased intestinal function.
|
Baseline and Month 3
|
Change from Baseline in Intestinal Function from Month 3 to Month 6
Time Frame: Month 3 and Month 6
|
Intestinal function/mass is measured by citrulline plasma levels.
Normal citrulline levels range from 20-50 umol/L.
Higher levels indicate increased intestinal function.
|
Month 3 and Month 6
|
Number of Adverse Events per Treatment Group
Time Frame: Baseline-Month 6
|
Adverse events will be documented from baseline to the end of the study (6 months) in the Zinc supplementation and Zinc optimized diet group.
|
Baseline-Month 6
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14999
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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