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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Multivitamin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivitamin | Dietary Supplement | 4 capsules of Perelel Health Conception Support Multivitamin Pack (consisting of vitamins, minerals, and omega ingredients) consumed daily for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline (week 0) to end of intervention (week 12) on Serum Folate | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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:
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.
Female
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Dinan, MD, PHD | Atlantia Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials | Cork | Munster | T23R50R | Ireland |
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| ID | Term |
|---|---|
| C067316 | Geritol |
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Randomised, double-blind, placebo-controlled, parallel study in healthy women.
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| Placebo | Dietary Supplement | 4 placebo capsules consumed daily for 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 |
| 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 |