Status:
COMPLETED
Impact of a MVM to Support Biomarkers Associated With Conception and Pregnancy in Healthy Women.
Lead Sponsor:
Perelel Inc.
Conditions:
Healthy Adult Women of Child Bearing Age
Eligibility:
FEMALE
21-40 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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:
- a. Vitamins/minerals (vitamin D, folate, vitamin B12)
- Current or recent (in the past 8 weeks) use of prohibited nutritional or non-nutritional supplements, including:
- Omega supplements
- Iron
- Individuals who, in the opinion of the investigator, are considered to be poor
- If the Participant has been in a recent experimental study involving drugs/supplements, these must have been completed not less than 90 days for drugs and 30 days for supplements prior to this study.
Key Trial Info
Start Date :
October 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06505408
Start Date
October 2 2024
End Date
January 20 2025
Last Update
June 6 2025
Active Locations (1)
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1
Atlantia Food Clinical Trials
Cork, Munster, Ireland, T23R50R