NCT04913467: Vita-GrAID

Effect of Ileocolonic Delivered Vitamins and an Anti-Inflammatory Diet on Crohn's Disease and Healthy Volunteers

Status unknown NA Last updated 14 February 2023

What this trial tests

NA trial testing Groningen Anti-Inflammatory Diet (GrAID) in Crohn Disease in 510 participants. Status unknown.

Timeline

8 October 2021

Primary endpoint
1 July 2024

1 July 2025

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	510
Start date	8 October 2021
Primary completion	1 July 2024
Estimated completion	1 July 2025
Sites	1 location across Netherlands

Drugs / interventions tested

• Groningen Anti-Inflammatory Diet (GrAID)
• ColoVit capsule
• ColoPulse-placebo capsule

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →

Sponsor

University Medical Center Groningen

Who can join

Adults 18 to 80, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate if the Groningen Anti-Inflammatory Diet and the ileocolonic delivery of vitamin B2, B3 and C can positively influence the course of Crohn's disease and can positively alter the gut microbiome of Crohn's disease patients as well as healthy volunteers.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vitamin C Supplementation in Healthy Individuals Leads to Shifts of Bacterial Populations in the Gut-A Pilot Study.
   Otten AT, Bourgonje AR, Peters V, Alizadeh BZ, et al · · 2021 · cited 41× · PMID 34439526 · DOI 10.3390/antiox10081278
2. Bile Salt Hydrolase-Competent Probiotics in the Management of IBD: Unlocking the "Bile Acid Code".
   Gadaleta RM, Cariello M, Crudele L, Moschetta A. · · 2022 · cited 39× · PMID 35956388 · DOI 10.3390/nu14153212
3. What Should I Eat? Dietary Recommendations for Patients with Inflammatory Bowel Disease.
   Saha S, Patel N. · · 2023 · cited 10× · PMID 36839254 · DOI 10.3390/nu15040896
4. Mining the Microbiome and Microbiota-Derived Molecules in Inflammatory Bowel Disease.
   Bekkers M, Bekkers M, Stojkovic B, Kaiko GE. · · 2021 · cited 10× · PMID 34681902 · DOI 10.3390/ijms222011243
5. Microbial micronutrient sharing, gut redox balance and keystone taxa as a basis for a new perspective to solutions targeting health from the gut.
   Steinert RE, Rehman A, Sadabad MS, Milanese A, et al · · 2025 · cited 8× · PMID 40090884 · DOI 10.1080/19490976.2025.2477816
6. Effects of ileocolonic delivered vitamin B₂, B₃ and C (ColoVit) or the Groningen anti-inflammatory diet on disease course and microbiome of patients with Crohn's disease (VITA-GrAID study): a protocol for a randomised and partially blinded trial.
   Otten AT, Peters V, Barth I, Stevens CL, et al · · 2023 · cited 5× · PMID 36918234 · DOI 10.1136/bmjopen-2022-069654
7. Capsules with Ileocolonic-Targeted Release of Vitamin B₂, B₃, and C (ColoVit) Intended for Optimization of Gut Health: Development and Validation of the Production Process.
   Ahmed AA, Otten AT, Gareb B, Huijmans JE, et al · · 2023 · cited 3× · PMID 37242596 · DOI 10.3390/pharmaceutics15051354
8. Anti-inflammatory dietary interventions in inflammatory bowel disease: current insights and future perspectives
   Li M, Jiang C, Wang B, Guan Z, et al ·