Viewing Study NCT06505408



Ignite Creation Date: 2024-10-25 @ 8:04 PM
Last Modification Date: 2024-10-26 @ 3:35 PM
Study NCT ID: NCT06505408
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-07-11

Brief Title: Impact of a MVM to Support Biomarkers Associated With Conception and Pregnancy in Healthy Women
Sponsor: None
Organization: None

Study Overview

Official Title: Evaluating the Impact of a Multivitamin Supplement to Support Biomarkers Associated With Conception and Pregnancy in Healthy Women
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 Vitamin D Iron Folate

Secondary Objective To evaluate in healthy women the effect of 12-week long daily administration of multivitamin MVM on overall health and wellness self reported stress anxiety and depression and

Vitamin B12
RBC Fatty Acid of Omega-3 DHA and EPA and Omega-6 CLA and AA
Ratio Omega 6 Omega 3 calculated
Choline
CoQ10
C-Reactive Protein CRP

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None