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NCT05782257
Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet
NA trial testing Zinc Supplementation in Celiac Disease in 50 participants. Status unknown.
1 September 2024
Quick facts
| Lead sponsor | McMaster University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 8 December 2022 |
| Primary completion | 1 September 2024 |
| Estimated completion | 1 September 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Zinc Supplementation — full drug profile →
- Zn-Optimized Diet
Conditions studied
- Celiac Disease — all drugs for Celiac Disease →
- Nutrient Deficiency — all drugs for Nutrient Deficiency →
Sponsor
McMaster University
Who can join
18 and older, any sex, with Celiac Disease or Nutrient Deficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05782257
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05782257 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McMaster University
- Last refreshed: 23 March 2023
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