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NCT05393843: PREDIP2
Prevention of Maternal and Fetal Metabolic Complications With Diet and Nutraceutical Supplementation in Pregnant Women Affected by Gestational Diabetes: a Randomized, Double-blind Placebo Controlled Trial.
Phase 4 trial testing omega-3 fatty acids, anthocyanins and alpha-cyclodextrins in Gestational Diabetes in 51 participants. Terminated before completion.
1 March 2020
Quick facts
| Lead sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 51 |
| Start date | 1 May 2018 |
| Primary completion | 1 March 2020 |
| Estimated completion | 1 March 2020 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- omega-3 fatty acids, anthocyanins and alpha-cyclodextrins
- diet
- placebo
Conditions studied
- Gestational Diabetes — all drugs for Gestational Diabetes →
- Oxidative Stress — all drugs for Oxidative Stress →
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Who can join
18 and older, female only, with Gestational Diabetes or Oxidative Stress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Our trial aims to assess the effect of nutraceutical supplements (omega-3 fatty acids, anthocyanins and alpha-cyclodextrins) in patients affected by gestational diabetes. Pregnant women with gestational diabetes at 24-28 weeks of gestation are enrolled in a double-blind trial and randomized to receive either nutraceutical supplements or a placebo for 12 weeks.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dietary Polyphenols against Oxidative Stress in Head and Neck Cancer: What's New, What's Next.
Ballini A, Zhurakivska K, Troiano G, Lo Muzio L, et al · · 2024 · cited 7× · PMID 38169656 · DOI 10.7150/jca.90545 -
The Effect of Alpha-Cyclodextrin on Postprandial Glucose Excursions: a Systematic Meta-Analysis.
Wittkowski KM. · · 2022 · cited 4× · PMID 36349072 · DOI 10.7759/cureus.31160 -
Gestational diabetes severity stratification during pregnancy: role of plasma oleic acid as a possible early marker.
Soldavini CM, Piuri G, Corsetto PA, Colombo I, et al · · 2025 · PMID 40167637 · DOI 10.1007/s00592-025-02487-2
Verify or expand the search:
- PubMed search for NCT05393843
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07174245 — Pregnancy and Postpartum CGM in GDM · recruiting
Other Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico trials
Trials by the same sponsor.
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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 NCT05393843 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Last refreshed: 26 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05393843.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing