Celiac DiseaseNCT05782257

Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet

A study testing Zinc Supplementation and Zn-Optimized Diet in people with Celiac Disease and Nutrient Deficiency, run by McMaster University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Celiac Disease, Nutrient Deficiency
What is being tested?: Zinc Supplementation and Zn-Optimized Diet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteCanada
Study dates: 8 Dec 2022to 1 Sep 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting

McMaster University
Hamilton
Shilpa Tandon, BSc, 9055212100 ext. 21875, tandos1@mcmaster.ca
Maria Ines Pinto-Sanchez, MD
Recruiting

Other trials in Canada

About this study

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

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.

Conditions: Celiac Disease, Nutrient Deficiency
Being tested: Zinc Supplementation, Zn-Optimized Diet
Keywords: Zinc deficiency, Microbiome, Gastrointestinal and extra-intestinal symptoms, Supplementation, Dietary Treatment, Feasibility
Medical subject headings: Celiac Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zinc SupplementationDietary supplement
Take one 25mg Zn gluconate tablet daily
Zn-Optimized DietOther
Consume 11 mg/day of zinc-rich foods for females and 14 mg/day in males.

Study groups in NCT05782257
Study group	Role	What they receive
Zinc Supplementation	Active comparator	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 Receives: Dietary Supplement: Zinc Supplementation
Zinc Optimized Diet	Experimental	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. Receives: Other: Zn-Optimized Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months
Compliance of Supplementation Therapy
To assess compliance to zinc supplementation therapy. Supplementation compliance is measured by pill counting.
Measured: 6 months

Secondary outcomes (11)

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)
Measured: Baseline and Month 3
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)
Measured: Month 3 and Month 6
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)
Measured: Baseline and Month 3
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)
Measured: Month 3 and Month 6
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).
Measured: Baseline and Month 3
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).
Measured: Month 3 and Month 6
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).
Measured: Baseline and Month 3
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).
Measured: Month 3 and Month 6
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.
Measured: Baseline and Month 3
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.
Measured: Month 3 and Month 6
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.
Measured: Baseline-Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Dec 20221 Sep 2024

First posted23 Mar 2023
Study start8 Dec 2022
Primary completion1 Sep 2024 (estimated)
Study completion1 Sep 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Celiac DiseaseStudies of the same condition, open and under way.
More trials run by McMaster UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05782257
Sponsor's protocol ID: 14999
Status last verified: Mar 2023
First submitted: 29 Dec 2022
Last updated: 23 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Celiac Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05782257
Acronym / sponsor ID: 14999
Conditions: Celiac Disease, Nutrient Deficiency
Keywords: Zinc deficiency, Microbiome, Gastrointestinal and extra-intestinal symptoms, Supplementation, Dietary Treatment, Feasibility
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: McMaster UniversityUniversity, hospital or other
Collaborators: Hamilton Health Sciences Corporation
Study start: 8 Dec 2022 (actual)
Primary completion: 1 Sep 2024 (estimated)
Study completion: 1 Sep 2024 (estimated)
First posted: 23 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Zinc Supplementation	Active comparator	Dietary Supplement: Zinc SupplementationThose 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
Zinc Optimized Diet	Experimental	Other: Zn-Optimized DietInstructions 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zinc SupplementationTake one 25mg Zn gluconate tablet daily	Dietary supplement	Zinc Supplementation
Zn-Optimized DietConsume 11 mg/day of zinc-rich foods for females and 14 mg/day in males.	Other	Zinc Optimized Diet

Primary outcome

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.
Compliance of Supplementation Therapy
Time frame: 6 months
To assess compliance to zinc supplementation therapy. Supplementation compliance is measured by pill counting.

11 secondary outcomes

Change from Baseline in Zinc Plasma Levels at Month 3
Time frame: Baseline and Month 3
Change in Zinc Plasma Levels from Month 3 to Month 6
Time frame: Month 3 and Month 6
Change from Baseline in Celiac Disease Symptoms at Month 3
Time frame: Baseline and Month 3
Change in Celiac Disease Symptoms from Month 3 to Month 6
Time frame: Month 3 and Month 6
Change from Baseline in Extra-Intestinal Symptoms at Month 3
Time frame: Baseline and Month 3
Change in Extra-Intestinal Symptoms from Month 3 to Month 6
Time frame: Month 3 and Month 6
Change from Baseline in Depression and Anxiety Symptoms at Month 3
Time frame: Baseline and Month 3
Change in Depression and Anxiety Symptoms from Month 3 to Month 6
Time frame: Month 3 and Month 6
Change from Baseline in Intestinal Function at Month 3
Time frame: Baseline and Month 3
Change from Baseline in Intestinal Function from Month 3 to Month 6
Time frame: Month 3 and Month 6
Number of Adverse Events per Treatment Group
Time frame: Baseline-Month 6

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.

Related trials for Celiac Disease

Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
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RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

McMaster University

Hamilton, Canada

9055212100 ext. 21875

tandos1@mcmaster.ca

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Zinc Supplementation and Zn-Optimized Diet in people with Celiac Disease and Nutrient Deficiency, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance of Dietary Therapy (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05782257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.