NCT06505408

Impact of a MVM to Support Biomarkers Associated With Conception and Pregnancy in Healthy Women.

Evaluating the Impact of a Multivitamin Supplement to Support Biomarkers Associated With Conception and Pregnancy in Healthy Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Perelel Inc. · Industry
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to investigate the effects multivitamin (MVM) on blood biomarkers that are associated with healthy pregnancy and conception in adult women. The main question it aims to answer is: Is there a significant change in blood biomarkers from baseline (week 0) to end of intervention (week 12) in healthy women consuming multivitamin compared to participants consuming the placebo product? Participants will: Take drug MVM or a placebo every day for 12 weeks Visit the clinic at baseline and 12 weeks for serum blood draws and measurements Complete a series of surveys at baseline and 12 weeks

Detailed description

A 12 week double-blind, placebo-controlled, clinical trial assessing the daily administration of a multivitamin (MVM) or placebo on blood biomarkers associated with healthy pregnancy and conception in healthy adult women. Participants will consume study product or placebo for 12 weeks. Measurements will be taken at baseline and at the end of 12 weeks. Primary Objective: To evaluate in healthy women, the effect of 12-week long daily administration of a multivitamin (MVM) on blood biomarkers associated with healthy pregnancy (Folate). Secondary Objective: To evaluate in healthy women, the effect of 12-week long daily administration of multivitamin (MVM) on blood biomarkers associated with healthy pregnancy * Vitamin B12 * Iron * Omega-3 * Choline * CoQ10

Conditions

• Healthy Adult Women of Child Bearing Age

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Multivitamin	4 capsules of Perelel Health Conception Support Multivitamin Pack (consisting of vitamins, minerals, and omega ingredients) consumed daily for 12 weeks
DIETARY_SUPPLEMENT	Placebo	4 placebo capsules consumed daily for 12 weeks

Timeline

• Start date: 2024-10-02
• Primary completion: 2025-01-20
• Completion: 2025-01-20
• First posted: 2024-07-17
• Last updated: 2025-06-06

Locations

1 site across 1 country: Ireland