NCT07296562

Expert Consensus on the Use of Nutraceuticals in Pregnancy: A Delphi Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Venus Research Center · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This study is a Delphi-based expert consensus project aimed at developing evidence-informed recommendations for the safe and effective use of nutriceuticals during pregnancy. Despite widespread use of vitamins, minerals, and other dietary supplements in prenatal care, significant variability exists in clinical practice regarding indications, dosing, timing, and safety monitoring.

Detailed description

This study is a non-interventional, methodological Delphi consensus project designed to develop standardized recommendations for the use of nutriceuticals during pregnancy. Nutriceuticals, including vitamins, minerals, antioxidants, omega-3 fatty acids, and herbal supplements, are commonly used to support maternal health and fetal development. However, evidence regarding optimal dosing, timing, and safety profiles is inconsistent, and practice patterns vary globally. A steering committee of experts in obstetrics, maternal-fetal medicine, and clinical nutrition will conduct a thorough literature review and draft initial statements addressing key domains: Indications for nutriceutical use (routine supplementation, deficiency prevention, high-risk pregnancies) Recommended dosing and timing for common nutriceuticals (folic acid, iron, vitamin D, iodine, omega-3 fatty acids, etc.) Safety considerations and contraindications (including herbal and non-standard supplements) Monitoring strategies for maternal and fetal safety Integration with dietary and lifestyle interventions Counseling and patient education A panel of experts in obstetrics and maternal nutrition will participate in multiple Delphi rounds. Panelists will rate each statement on a Likert scale for agreement. After each round, anonymized feedback will be provided, and statements not reaching the predefined consensus threshold (e.g., ≥70-80%) will be revised for subsequent evaluation. The final output will consist of consensus-based recommendations for nutriceutical use in pregnancy, highlighting areas of strong agreement, areas of uncertainty, and research priorities. These recommendations aim to support safe, evidence-informed clinical practice for maternal and fetal health.

Conditions

• Nutraceuticals
• Pregnancy

Timeline

• Start date: 2026-01-25
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2025-12-22
• Last updated: 2025-12-22

Locations

1 site across 1 country: Egypt