Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet (NCT05782257) | Clinical Trial Compass
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Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet
Canada50 participantsStarted 2022-12-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing dietary changes versus zinc supplements to treat zinc deficiency in celiac disease — given my current situation, which of those two approaches would my doctor think is more realistic for me to stick with long-term?
2Since this trial's recruitment status is listed as unknown, is it actually still enrolling patients, and how would my doctor suggest I find out if it's still an option?
3The trial seems focused on measuring how well people follow each treatment approach rather than long-term health outcomes — does that mean there's still a lot we don't know about which method is actually better at correcting zinc deficiency in celiac disease?
4Before considering this trial, should I first get my zinc levels tested to confirm I actually have a deficiency, and is zinc deficiency something my doctor would typically address as part of my regular celiac disease care anyway?
5If I'm already on a strict gluten-free diet for my celiac disease, how would adding either a zinc-focused dietary change or a supplement regimen on top of that affect the demands on my daily life, and is that something worth discussing before deciding whether to explore this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.