Healthy Adult Women of Child Bearing AgeNCT06505408
Impact of a MVM to Support Biomarkers Associated With Conception and Pregnancy in Healthy Women.
A study testing Multivitamin in people with Healthy Adult Women of Child Bearing Age, run by Perelel Inc. at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Women of Child Bearing Age
- What is being tested?
- Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- 2 Oct 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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:
- 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:
- Oral contraceptive pills
- Current or recent (in the past 4 weeks) use of prohibited nutritional or non-nutritional supplements, including:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Impact of a Multivitamin Supplement to Support Biomarkers Associated With Conception and Pregnancy in Healthy Women
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
Read the 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
- Being tested
- Multivitamin, Placebo
- Keywords
- Multivitamin, Healthy women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultivitaminDietary supplement
Also called MVM
4 capsules of Perelel Health Conception Support Multivitamin Pack (consisting of vitamins, minerals, and omega ingredients) consumed daily for 12 weeks
PlaceboDietary supplement
4 placebo capsules consumed daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Multivitamin | Experimental | Not described Receives: Dietary Supplement: Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (week 0) to end of intervention (week 12) on Serum Folate
Measured: 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]
Measured: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on Serum Vitamin B12
Measured: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on Ratio Omega 6: Omega 3 (calculated)
Measured: 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)
Measured: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on plasma Choline
Measured: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on plasma CoQ10
Measured: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on serum C-Reactive Protein (CRP)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start2 Oct 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Women of Child Bearing AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double-blind, placebo-controlled, parallel study in healthy women.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perelel Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, MD, PHD, Principal investigator, Atlantia Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505408
- Sponsor's protocol ID
- AFRCO-182
- Status last verified
- Jun 2025
- First submitted
- 11 Jul 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Multivitamin Supplement to Support Biomarkers Associated With Conception and Pregnancy in Healthy Women
- ClinicalTrials.gov ID
- NCT06505408
- Acronym / sponsor ID
- AFRCO-182
- Conditions
- Healthy Adult Women of Child Bearing Age
- Keywords
- Multivitamin, Healthy women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Perelel Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised, double-blind, placebo-controlled, parallel study in healthy women.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Multivitamin | Experimental | Dietary Supplement: Multivitamin |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MultivitaminAlso: MVM4 capsules of Perelel Health Conception Support Multivitamin Pack (consisting of vitamins, minerals, and omega ingredients) consumed daily for 12 weeks | Dietary supplement | Multivitamin |
| Placebo4 placebo capsules consumed daily for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Change from baseline (week 0) to end of intervention (week 12) on Serum Folate
Time frame: 12 weeks
7 secondary outcomes
Change from baseline (week 0) to end of intervention (week 12) on Serum Iron [including Ferritin, Total Iron Binding Capacity (TIBC) and Transferrin]
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on Serum Vitamin B12
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on Ratio Omega 6: Omega 3 (calculated)
Time frame: 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)
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on plasma Choline
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on plasma CoQ10
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on serum C-Reactive Protein (CRP)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Dinan, MD, PHD principal investigator
Atlantia Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamin in people with Healthy Adult Women of Child Bearing Age, run by Perelel Inc. at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline (week 0) to end of intervention (week 12) on Serum Folate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.