Safety and Tolerability of a Combination of Curcumin, Omega-3 and Vitamin D: Results from the PASCOD Study, an RA Prevention Protocol
Notice bibliographique
Résumé
Objectives Rheumatoid arthritis (RA) is an inflammatory autoimmune arthritis for which there is currently no cure. Recent research has focused on prevention strategies in individuals at increased risk of RA with the aim of reducing this risk. One such strategy involves dietary interventions. In a secondary analysis of a large prospective clinical trial (VITAL), vitamin D and omega-3 fatty acid supplementation have shown promise in reducing incident RA.[1] In a collagen induced arthritis murine model of RA, we showed that a diet supplemented with Curcumin, omega-3 and vitamin D (COD) reduced arthritis severity and incidence when given during the induction phase.[2] Based on these considerations, we are planning a prospective RA prevention trial using COD in anticitrullinated protein antibody (ACPA) positive individuals. However, there are no clinical trials which have evaluated the combined use of COD in humans. Thus, we conducted PASCOD (Pilot Assessment and Safety of COD) to evaluate the safety and tolerability of COD in healthy human volunteers. Methods Healthy volunteers aged 18-49 years with no history of RA or other autoimmune diseases were recruited (n=50) for a 4-week open-label pre-post design. Baseline visits included overall health and medications survey, anthropometric measures, functional status (RAPID3), a joint symptom questionnaire and a clinical assessment of 44 joints, all of which were repeated at the final visit. Blood specimens were collected for routine hematology and biochemistry. The study was powered to detect the rate of common side effects (>5% frequency), which was the primary outcome. Results Most reported side effects were mild (81.8%), with the most common, being heartburn (32%), fishy taste (30%), and abdominal bloating (24%), which mostly improved over time. Mean adherence was 97% for all 3 supplements. Reflective of this, we observed increases in eicosapentaenoic acid (EPA, p<0.0001), docosahexaenoic acid (DHA, p<0.0001) levels measured in plasma by gas chromatography, and vitamin D levels (p=0.01). Despite the absence of inflammatory arthritis, RAPID3 scores significantly decreased over the trial (p=0.048), driven by a reduction in self-reported joint pain visual analog scale (VAS, p=0.002). Self-reported joint pain score (p=0.008), fatigue VAS (p=0.008) and minutes of AM stiffness (p=0.01) all reduced after COD treatment (Figure). Conclusion Overall, 4 weeks of COD was well-tolerated, with high adherence and mild side effects which mostly improved over time. We observed improvements in self-reported symptoms relevant to individuals at risk for future RA development. This data suggests that COD supplementation is a feasible strategy for consideration in an RA prevention trial. [1.] Hahn J. BMJ 2022:376:e066452. [2.] Hemshekhar M. Arthritis Res Ther 2021;23(1):39.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,007 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,003 | 0,001 |
| Méta-épidémiologie (sens large) | 0,004 | 0,002 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,002 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,008 | 0,002 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».