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

NCT06505408 | Completed

• 1 other identifier: AFRCO-182
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Adult Women of Child Bearing Age

Keywords

Multivitamin; Healthy women

Outcome Measures

Primary Outcomes (1)

• Change from baseline (week 0) to end of intervention (week 12) on Serum Folate

  12 weeks

Secondary Outcomes (7)

• 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 Vitamin B12

  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 plasma Choline

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Multivitamin

EXPERIMENTAL

Dietary Supplement: Multivitamin

Interventions

Multivitamin DIETARY_SUPPLEMENT

4 capsules of Perelel Health Conception Support Multivitamin Pack (consisting of vitamins, minerals, and omega ingredients) consumed daily for 12 weeks

Also known as: MVM

Multivitamin

Placebo DIETARY_SUPPLEMENT

4 placebo capsules consumed daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be able to give written informed consent.
• Be between 21- 40 years of age (inclusive).
• Regular menstrual cycles in the past 6 months.
• Willing to consume the study product daily for the duration of the study.

You may not qualify if:

• Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
• Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
• Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
• Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
• Sexual partner(s) is/are exclusively female.
• Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation. The Participant must be using this method for at least one week prior to and one week following the end of the study.
• Has a history of drug and/or alcohol abuse at the time of enrolment.
• Is a smoker.
• Is hypersensitive to any of the contents of the study product, that would preclude intake of the study products.
• Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history.
• Excluded health conditions include:
• a. Diabetes mellitus b. Cardiovascular disease c. Class II/III obesity (defined as BMI ≥35.0 Kg/m2)
• Current or recent (in the past 12 weeks) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
• a. Oral contraceptive pills
• Current or recent (in the past 4 weeks) use of prohibited nutritional or non-nutritional supplements, including:

Sponsors & Collaborators

• Perelel Inc.: lead

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Munster, T23R50R, Ireland

Location

MeSH Terms

Interventions

Geritol

Study Officials

• Timothy Dinan, MD, PHD

  Atlantia Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, double-blind, placebo-controlled, parallel study in healthy women.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: October 2, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)