Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet

NCT05782257 | Unknown

• 1 other identifier: 14999
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Zinc deficiency; Microbiome; Gastrointestinal and extra-intestinal symptoms; Supplementation; Dietary Treatment; Feasibility

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• Compliance of Supplementation Therapy

  To assess compliance to zinc supplementation therapy. Supplementation compliance is measured by pill counting.

  6 months

Secondary Outcomes (11)

• Change from Baseline in Zinc Plasma Levels at Month 3

  Baseline and Month 3

• Change in Zinc Plasma Levels from Month 3 to Month 6

  Month 3 and Month 6

• Change from Baseline in Celiac Disease Symptoms at Month 3

  Baseline and Month 3

• Change in Celiac Disease Symptoms from Month 3 to Month 6

  Month 3 and Month 6

• Change from Baseline in Extra-Intestinal Symptoms at Month 3

  Baseline and Month 3

Study Arms (2)

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

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.

Other: Zn-Optimized Diet

Interventions

Zinc Supplementation DIETARY_SUPPLEMENT

Take one 25mg Zn gluconate tablet daily

Zinc Supplementation

Zn-Optimized Diet OTHER

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

Zinc Optimized Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

McMaster University

Hamilton, Canada

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: March 23, 2023
• Study Start: December 8, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

CA (1)