Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet

NCT ID: NCT05782257

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2024-09-01

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.

Conditions

Celiac Disease; Nutrient Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Zinc Supplementation

Intervention Type: DIETARY_SUPPLEMENT

Take one 25mg Zn gluconate tablet daily

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.

Group Type: EXPERIMENTAL

Zn-Optimized Diet

Intervention Type: OTHER

Consume 11 mg/day of zinc-rich foods for females and 14 mg/day in males.

Interventions

Zinc Supplementation

Take one 25mg Zn gluconate tablet daily

Intervention Type: DIETARY_SUPPLEMENT

Zn-Optimized Diet

Consume 11 mg/day of zinc-rich foods for females and 14 mg/day in males.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Maria Ines Pinto Sanchez

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McMaster University

Hamilton, , Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Shilpa Tandon, BSc

Role: primary

tandos1@mcmaster.ca

9055212100 ext. 21875

Other Identifiers

14999

Identifier Type: -

Identifier Source: org_study_id