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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Take one 25mg Zn gluconate tablet daily
Consume 11 mg/day of zinc-rich foods for females and 14 mg/day in males.
McMaster University
Hamilton, Canada
RECRUITINGCompliance 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.
Time frame: 6 months
Compliance of Supplementation Therapy
To assess compliance to zinc supplementation therapy. Supplementation compliance is measured by pill counting.
Time frame: 6 months
Change from Baseline in Zinc Plasma Levels at Month 3
Plasma Zinc will be measured through bloodwork. Normal plasma zinc (pZn) levels: 9.4 ≤ pZn ≤ 15 ug/dL. Change = (Month 3 - Baseline)
Time frame: Baseline and Month 3
Change in Zinc Plasma Levels from Month 3 to Month 6
Plasma Zinc will be measured through bloodwork. Normal plasma zinc (pZn) levels: 9.4 ≤ pZn ≤ 15 ug/dL. Change = (Month 6- Month 3)
Time frame: Month 3 and Month 6
Change from Baseline in Celiac Disease Symptoms at Month 3
The Celiac Symptoms Index (CSI) is a validated disease-specific symptom index in adults with celiac disease. Possible total scores range from 16 (no symptoms) to 80 (worst possible symptoms). Higher scores indicate increase in severity of symptoms. Change = (Month 3 - baseline)
Time frame: Baseline and Month 3
Change in Celiac Disease Symptoms from Month 3 to Month 6
The Celiac Symptoms Index (CSI) is a validated disease-specific symptom index in adults with celiac disease. Higher scores indicate increase in severity of symptoms. Possible total scores range from 16 (no symptoms) to 80 (worst possible symptoms). Change = (Month 6 - Month 3)
Time frame: Month 3 and Month 6
Change from Baseline in Extra-Intestinal Symptoms at Month 3
The Visual Analog Scale (VAS) is a validated subjective measure of acute and chronic pain. Possible total scores range from 0 (no symptoms) to 100 (very severe symptoms). Higher scores indicate increase in severity of symptoms. Change = (Month 3 - Baseline).
Time frame: Baseline and Month 3
Change in Extra-Intestinal Symptoms from Month 3 to Month 6
The Visual Analog Scale (VAS) is a validated subjective measure of acute and chronic pain. Possible total scores range from 0 (no symptoms) to 100 (very severe symptoms). Higher scores indicate increase in severity of depression and anxiety. Change = (Month 6 - Month 3).
Time frame: Month 3 and Month 6
Change from Baseline in Depression and Anxiety Symptoms at Month 3
The Hospital Anxiety and Depression Scale (HADS) is a questionnaire assessing patient anxiety and depression. Possible scores range from 0 (normal) to 21 (abnormal). Higher scores indicate increase in severity of depression and anxiety. Change = (Month 3- Baseline).
Time frame: Baseline and Month 3
Change in Depression and Anxiety Symptoms from Month 3 to Month 6
The Hospital Anxiety and Depression Scale (HADS) is a questionnaire assessing patient anxiety and depression. Possible scores range from 0 (normal) to 21 (abnormal). Higher scores indicate increase in severity of depression and anxiety. Change = (Month 6- Month 3).
Time frame: Month 3 and Month 6
Change from Baseline in Intestinal Function at Month 3
Intestinal function/mass is measured by citrulline plasma levels. Normal citrulline levels range from 20-50 umol/L. Higher levels indicate increased intestinal function.
Time frame: Baseline and Month 3
Change from Baseline in Intestinal Function from Month 3 to Month 6
Intestinal function/mass is measured by citrulline plasma levels. Normal citrulline levels range from 20-50 umol/L. Higher levels indicate increased intestinal function.
Time frame: Month 3 and Month 6
Number of Adverse Events per Treatment Group
Adverse events will be documented from baseline to the end of the study (6 months) in the Zinc supplementation and Zinc optimized diet group.
Time frame: Baseline-Month 6
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