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Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet

NCT05782257 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-03-23

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Zinc Supplementation

Take one 25mg Zn gluconate tablet daily

OTHER

Zn-Optimized Diet

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05782257 on ClinicalTrials.gov