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

December 8, 2025 updated by: Venus Research Center
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.

Study Overview

Status

Enrolling by invitation

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Venus Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

he study population will consist of a purposive sample of experts in obstetrics, maternal-fetal medicine, and clinical nutrition who are actively involved in prenatal care and have experience or knowledge regarding the use of nutriceuticals in pregnancy.

Panel Size and Rationale:

Target enrollment: 20-35 experts.

Sufficient to capture diverse perspectives while remaining feasible for multiple Delphi rounds.

Minimum for analysis: 15 panelists, ensuring representativeness in case of attrition.

Description

Inclusion Criteria:

  • Board-certified obstetricians, maternal-fetal medicine specialists, or clinical nutritionists with ≥5 years of relevant clinical experience.

Active involvement in prenatal care and experience or knowledge in nutriceutical use during pregnancy.

Engagement in clinical teaching, research, guideline development, or professional society activities related to maternal health or nutrition.

Willingness and availability to participate in all Delphi rounds.

Provision of informed consent to participate.

Exclusion Criteria:

  • Non-obstetric or non-nutrition specialty.

Less than 5 years of relevant clinical experience.

Limited or no experience with nutriceutical counseling/prescribing in pregnancy.

Significant undisclosed conflict of interest related to nutriceutical products.

Inability or unwillingness to participate in all Delphi rounds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Expert Panel
The study population will consist of a purposive sample of experts in obstetrics, maternal-fetal medicine, and clinical nutrition who are actively involved in the care of pregnant patients and have experience or knowledge regarding the use of nutriceuticals in pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: 6-12 weeks
Level of expert consensus on statements regarding nutraceutical use in pregnancy, measured as the proportion of panelists reaching the predefined agreement threshold (e.g., ≥70-80%) for each statement across Delphi rounds.
6-12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcome
Time Frame: 6-12 weeks

Consensus on indications for specific nutriceuticals (e.g., folic acid, iron, vitamin D, omega-3 fatty acids, iodine, herbal supplements).

Consensus on optimal dosing, timing, and duration of supplementation.

Consensus on safety monitoring protocols, including laboratory assessments and maternal/fetal surveillance.

Consensus on contraindications and risk mitigation strategies for nutriceutical use.

Consensus on integration with dietary and lifestyle interventions.

Identification of areas of uncertainty requiring further research.
6-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Venus Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Nutriceuticals in Pregnancy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Delphi studies do not collect patient data, medical records, biological samples, or identifiable clinical information. Experts only give opinions, not "IPD." Their responses are anonymized, and sharing identifiable expert-level responses is not required and often discouraged

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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