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

BMJ Open · 10 authors, 4 centres

AI SUMMARY

FIDELITY 100%

POPULATIONAdult patients with low-to-mildly active Crohn's disease (Harvey-Bradshaw Index <8, fecal calprotectin ≥100 µg/g) and their healthy household members

INTERVENTIONGroningen anti-inflammatory diet (GrAID) OR ileocolonic-targeted vitamin B2/B3/C capsule (ColoVit) twice daily for 12 weeks

COMPARISONPlacebo capsule (microcrystalline cellulose) twice daily for 12 weeks

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

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TL;DR

This protocol describes a randomized trial testing two dietary interventions for Crohn's disease: the Groningen anti-inflammatory diet (GrAID) and an ileocolonic-targeted vitamin B2/B3/C capsule (ColoVit). The primary outcome is change in fecal calprotectin after 12 weeks. If effective, these interventions could provide evidence-based dietary options for managing mild-to-moderate Crohn's disease.

Full summary

2,526 CHARS

**Background:** Diet is a key environmental factor in Crohn's disease (CD) onset and progression, but evidence-based dietary recommendations are lacking. The VITA-GrAID study aims to investigate two interventions: the Groningen anti-inflammatory diet (GrAID), which encourages anti-inflammatory foods and limits pro-inflammatory components, and ColoVit, an ileocolonic-targeted capsule containing riboflavin (vitamin B2), niacin (vitamin B3), and ascorbic acid (vitamin C). These vitamins may modulate gut microbiota and reduce inflammation.

**Methods:** This multicentre, randomised, placebo-controlled, partially blinded trial will recruit 255 CD patients with Harvey-Bradshaw Index <8 and fecal calprotectin (FCal) ≥100 µg/g from four hospitals in the Netherlands. Patients are randomised 1:1:1 to GrAID, ColoVit (37.5 mg riboflavin, 2.5 mg niacin, 250 mg ascorbic acid per capsule, twice daily), or placebo (microcrystalline cellulose capsule, twice daily). Healthy household members are allocated to the same group as the patient. The study has a 12-week interventional phase followed by a 9-month observational follow-up. The primary outcome for patients is change in FCal from baseline to 12 weeks; for healthy subjects, it is change in gut microbial composition. Secondary outcomes include flares (defined as FCal >200 µg/g and CDAI ≥220), clinical parameters (CDAI, medication use, surgery), quality of life (IBDQ, FR-QoL), nutritional status (anthropometry, BIA), faecal SCFAs, pH, redox potential, blood inflammatory/oxidative stress markers, and adherence. Sample size calculation was based on the RISE-UP study (riboflavin in CD, n=70) showing a mean FCal reduction from 883.8 µg/g (SD 885.0) to 669.6 µg/g (SD 398.8) (~24% reduction). With 80% power, α=0.05, and 30% dropout, 85 patients per group are needed. Statistical analysis will use intention-to-treat and per-protocol approaches, with multivariate generalised linear models for short-term differences and general linear mixed models for longitudinal data. Adjustments for multiple comparisons will use Benjamini-Hochberg (FDR 5%).

**Key Results:** Not applicable (protocol paper; no results reported).

**Clinical Implications:** This trial will provide high-quality evidence on two dietary interventions for CD. If effective, the GrAID offers a comprehensive dietary approach, while ColoVit provides a targeted vitamin supplement that may be easier to implement. Results could inform evidence-based dietary recommendations for patients and clinicians.

PICO

PPOPULATION

Adult patients with low-to-mildly active Crohn's disease (Harvey-Bradshaw Index <8, fecal calprotectin ≥100 µg/g) and their healthy household members

IINTERVENTION

Groningen anti-inflammatory diet (GrAID) OR ileocolonic-targeted vitamin B2/B3/C capsule (ColoVit) twice daily for 12 weeks

OOUTCOME

Primary: change in fecal calprotectin from baseline to 12 weeks (patients); change in gut microbial composition (healthy household members). Secondary: flares, clinical parameters, quality of life, nutritional status, microbiome, SCFAs, inflammatory markers, adherence.

STUDY TYPE

other

SPECIALTY

gastroenterology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10016306

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

BMJ Open

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ABSTRACT

Background Diet plays a pivotal role in the onset and progression of Crohn’s disease (CD). Nutritional interventions revealed effects on intestinal inflammation and gut microbial composition. However, data from well-designed and controlled dietary trials are lacking. Therefore, evidence-based dietary recommendations are still unavailable to patients and physicians. Here, we aim to investigate the effects of an evidence-based anti-inflammatory diet, and an ileocolonic-targeted capsule containing vitamin B 2 , B 3 and C (ColoVit) on patients with CD and their healthy household members. Methods and analysis In this multicentre, randomised, placebo-controlled, partially blinded nutritional intervention trial, we aim to recruit 255 CD patients with Harvey-Bradshaw Index <8 and a faecal calprotectin (FCal) cut-off of ≥100 µg/g at baseline. Participants will be randomised into two experimental intervention groups and one placebo group. In the experimental groups, participants will either adhere to the Groningen anti-inflammatory diet (GrAID) or ingest an ileocolonic-delivered oral vitamin B 2 /B 3 /C capsule (ColoVit). The study consists of a 12-week controlled interventional phase, which proceeds to a 9-month observational follow-up phase in which patients allocated to the GrAID group will be requested to continue the intervention on their own accord. Household members of participating patients will be asked to participate in the trial as healthy subjects and are allocated to the same group as their peer. The primary study outcome for patients is the change in FCal level from baseline. The primary outcome for household members is the change in gut microbial composition, which is set as secondary outcome for patients. Ethics and dissemination The protocol has been approved by the Institutional Review Board of the Stichting Beoordeling Ethiek Biomedisch Onderzoek in Assen, the Netherlands. Written informed consent will be obtained from all participants. Results will be disseminated through peer-reviewed journals and conference presentations. Trial registration number NCT04913467 .

CITATION EXPORT

Antonius Timotheus Otten, V Peters, I Barth et al.. 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. BMJ Open. (2023). https://doi.org/10.1136/bmjopen-2022-069654

AUTHORS

10 · 4 CENTRES

Antonius Timotheus Otten, V Peters, I Barth, C L Stevens, A R Bourgonje, H W Frijlink, H J M Harmsen, A Rehman, M J E Campmans-Kuijpers, G Dijkstra

1Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands
2Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands
3Department of Medical Microbiology, University Medical Centre Groningen, Groningen, The Netherlands
4DSM Nutritional Products AG, Kaiseraugst, Switzerland