Impact of a MVM to Support Biomarkers Associated With Conception and Pregnancy in Healthy Women.
NCT Number: NCT06505408
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Adult Women of Child Bearing Age
Interventions: DIETARY_SUPPLEMENT: Multivitamin|DIETARY_SUPPLEMENT: Placebo
Sponsor: Perelel Inc.
Sex: FEMALE
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-01
Locations: Atlantia Food Clinical Trials, Cork, Munster, T23R50R, Ireland

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

Primary Outcome Measures: Change from baseline (week 0) to end of intervention (week 12) on Serum vitamin D (25-hydroxy vitamin D), 12 weeks|Change from baseline (week 0) to end of intervention (week 12) on Serum Iron [including Ferritin, Total Iron Binding Capacity (TIBC) and Transferrin], 12 weeks|Change from baseline (week 0) to end of intervention (week 12) on Serum Folic Acid, 12 weeks
Secondary Outcome Measures: Changes in health and wellness as assessed by RAND SF-36, The RAND SF-36 is comprised of eight domains and 36 total items. The eight domains include: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. From the eight domains, each can be categorized into either physical or mental health, and such component summaries are then measured (Physical Component and Mental Component Summary). Questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible., 12 weeks|Changes in stress, anxiety, and depression levels as assessed by Depression Anxiety and Stress Scale-21 (DASS-21) scores., The Depression Anxiety Stress Scale is an abbreviated 21-item survey that measures the domains of depression, anxiety, and stress over the past week. Three DASS-21 scales are used for each domain and consist of 7 items using a 4-point severity/frequency scales with a 4 indicating the highest severity. Scores are calculated by summing the scores for the relevant items and multiplying by two with higher scores showing severity., 12 weeks|Change from baseline (week 0) to end of intervention (week 12) on Ratio Omega 6: Omega 3 (calculated), 12 weeks|Change from baseline (week 0) to end of intervention (week 12) on RBC Fatty Acid of Omega-3(DHA and EPA) and Omega-6 (CLA and AA), 12 weeks|Change from baseline (week 0) to end of intervention (week 12) on Serum Vitamin B12, 12 weeks|Change from baseline (week 0) to end of intervention (week 12) on plasma Choline, 12 weeks|Change from baseline (week 0) to end of intervention (week 12) on plasma CoQ10, 12 weeks|Change from baseline (week 0) to end of intervention (week 12) on serum C-Reactive Protein (CRP), 12 weeks