Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet
Celiac Disease, Nutrient Deficiency
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
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
Active Comparator
Experimental
Zinc Supplementation
Zinc Optimized Diet
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.