search
Back to results

Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet

Primary Purpose

Celiac Disease, Nutrient Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Zinc Supplementation
Zn-Optimized Diet
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring Zinc deficiency, Microbiome, Gastrointestinal and extra-intestinal symptoms, Supplementation, Dietary Treatment, Feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Zinc Supplementation

Zinc Optimized Diet

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Compliance of Dietary Therapy
To assess compliance to a zinc-optimized dietary treatment. Dietary compliance is measured through evaluating zinc levels from biweekly participant food diaries.
Compliance of Supplementation Therapy
To assess compliance to zinc supplementation therapy. Supplementation compliance is measured by pill counting.

Secondary Outcome Measures

Change from Baseline in Zinc Plasma Levels at Month 3
Plasma Zinc will be measured through bloodwork. Normal plasma zinc (pZn) levels: 9.4 ≤ pZn ≤ 15 ug/dL. Change = (Month 3 - Baseline)
Change in Zinc Plasma Levels from Month 3 to 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)
Change from Baseline in Celiac Disease Symptoms at 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)
Change in Celiac Disease Symptoms from Month 3 to 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)
Change from Baseline in Extra-Intestinal Symptoms at 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).
Change in Extra-Intestinal Symptoms from Month 3 to 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).
Change from Baseline in Depression and Anxiety Symptoms at 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).
Change in Depression and Anxiety Symptoms from Month 3 to 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).
Change from Baseline in Intestinal Function at 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.
Change from Baseline in Intestinal Function from Month 3 to 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.
Number of Adverse Events per Treatment Group
Adverse events will be documented from baseline to the end of the study (6 months) in the Zinc supplementation and Zinc optimized diet group.

Full Information

First Posted
December 29, 2022
Last Updated
March 10, 2023
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT05782257
Brief Title
Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Micronutrient deficiencies are common amongst celiac disease (CeD) patients due to consumption of a restrictive and nutritionally unbalanced gluten-free diet (GFD) in addition to slow intestinal villi healing. Preliminary data of 221 patients attending our Celiac Disease Clinic at McMaster University show that 64% of patients on a GFD have nutrient deficiencies with zinc (Zn) deficiency affecting 48% of treated CeD patients. Dietary supplements are prescribed to treat Zn deficiency and it is unclear whether Zn levels can be restored with optimizing Zn in diet. This project will evaluate the the feasibility of dietary therapy to treat Zn deficiency in CeD in comparison to supplementation. Additional objectives of this pilot study, are to assess the efficacy of Zn optimized GFD compared to Zn supplements in 1) normalizing plasma Zn levels and 2) improving CeD gastrointestinal and extra-intestinal symptoms at 3 and 6 month. Subjects will be recruited from McMaster Celiac clinic. This randomized controlled trial aims to recruit 50 CeD participants with two treatment groups; zinc optimized diet (guided by dietitian to achieve target of 11 mg/day for females and 14 mg /day for males) or zinc oral supplementation (25 mg zinc gluconate tablet/day; 7 mg elemental Zn) with a total study a total study period of 6 months and 4 visits. To be included in the study the investigators require celiac diagnosed patients confirmed through CeD serology and duodenal biopsies adhering to a GFD > 6 months and plasma Zn ≤9.3 µmol/L. Questionnaires will be used to assess presentation of symptoms, dietary adherence, quality of life, depression and anxiety. The trial would be considered to be feasible if the enrolment fraction (i.e., number of enrolled patients /number of eligible patients) is 60% or above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Nutrient Deficiency
Keywords
Zinc deficiency, Microbiome, Gastrointestinal and extra-intestinal symptoms, Supplementation, Dietary Treatment, Feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zinc Supplementation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Zinc Optimized Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc Supplementation
Intervention Description
Take one 25mg Zn gluconate tablet daily
Intervention Type
Other
Intervention Name(s)
Zn-Optimized Diet
Intervention Description
Consume 11 mg/day of zinc-rich foods for females and 14 mg/day in males.
Primary Outcome Measure Information:
Title
Compliance of Dietary Therapy
Description
To assess compliance to a zinc-optimized dietary treatment. Dietary compliance is measured through evaluating zinc levels from biweekly participant food diaries.
Time Frame
6 months
Title
Compliance of Supplementation Therapy
Description
To assess compliance to zinc supplementation therapy. Supplementation compliance is measured by pill counting.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Zinc Plasma Levels at Month 3
Description
Plasma Zinc will be measured through bloodwork. Normal plasma zinc (pZn) levels: 9.4 ≤ pZn ≤ 15 ug/dL. Change = (Month 3 - Baseline)
Time Frame
Baseline and Month 3
Title
Change in Zinc Plasma Levels from Month 3 to Month 6
Description
Plasma Zinc will be measured through bloodwork. Normal plasma zinc (pZn) levels: 9.4 ≤ pZn ≤ 15 ug/dL. Change = (Month 6- Month 3)
Time Frame
Month 3 and Month 6
Title
Change from Baseline in Celiac Disease Symptoms at Month 3
Description
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)
Time Frame
Baseline and Month 3
Title
Change in Celiac Disease Symptoms from Month 3 to Month 6
Description
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)
Time Frame
Month 3 and Month 6
Title
Change from Baseline in Extra-Intestinal Symptoms at Month 3
Description
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).
Time Frame
Baseline and Month 3
Title
Change in Extra-Intestinal Symptoms from Month 3 to Month 6
Description
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).
Time Frame
Month 3 and Month 6
Title
Change from Baseline in Depression and Anxiety Symptoms at Month 3
Description
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).
Time Frame
Baseline and Month 3
Title
Change in Depression and Anxiety Symptoms from Month 3 to Month 6
Description
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).
Time Frame
Month 3 and Month 6
Title
Change from Baseline in Intestinal Function at Month 3
Description
Intestinal function/mass is measured by citrulline plasma levels. Normal citrulline levels range from 20-50 umol/L. Higher levels indicate increased intestinal function.
Time Frame
Baseline and Month 3
Title
Change from Baseline in Intestinal Function from Month 3 to Month 6
Description
Intestinal function/mass is measured by citrulline plasma levels. Normal citrulline levels range from 20-50 umol/L. Higher levels indicate increased intestinal function.
Time Frame
Month 3 and Month 6
Title
Number of Adverse Events per Treatment Group
Description
Adverse events will be documented from baseline to the end of the study (6 months) in the Zinc supplementation and Zinc optimized diet group.
Time Frame
Baseline-Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
McMaster University
City
Hamilton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shilpa Tandon, BSc
Phone
9055212100
Ext
21875
Email
tandos1@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Maria Ines Pinto-Sanchez, MD

12. IPD Sharing Statement

Learn more about this trial

Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet

We'll reach out to this number within 24 hrs