We just completed our first IRB approved study through Needed Labs to examine nutritional characteristics in pregnant US women.
Summary of the Science
At Needed, advancing women’s health through research is core to our mission. That’s why we created Needed Labs—a platform to uncover new data, generate clinical insights, and elevate the standard of perinatal nutrition.
Despite widespread use of prenatal vitamins, up to 95% of women remain nutritionally depleted.
Most prenatal supplements are formulated to meet basic recommendations for certain nutrients, but may fall short in key nutrients evidenced to support optimal health in pregnancy. Compounding the issue, many women receive limited nutritional guidance in standard prenatal care, and data on micronutrient status in pregnant US women are still lacking.
See our white paper for a comprehensive analysis of the current state of research on perinatal nutrition.
To help fill this gap, we conducted the Prenatal Nutrient Status Study, our first IRB-approved clinical study—an observational, cross-sectional analysis of blood nutrient levels in pregnant women taking commonly used prenatal vitamins. We also included a smaller group of women taking the Needed Prenatal Multi to explore how micronutrient status might differ by supplement type.
Our findings were clear:
Women taking the Needed Prenatal Multi had significantly higher blood levels of key nutrients like vitamin D, vitamin B6, riboflavin, vitamin B12, vitamin K2, and selenium. They were also more likely to meet sufficiency thresholds for blood levels of vitamin D, vitamin B6, selenium, and zinc compared to those taking standard prenatals.
This research underscores the importance of optimized, evidence-based prenatal nutrition. We’re currently submitting our findings for peer-reviewed publication and sharing them at upcoming scientific conferences, reinforcing our commitment to transparency, scientific rigor, and better support for women through every stage of motherhood.
For the scientifically curious - let's dive into the details!
Why is more research needed on nutritional characteristics in pregnant women?
Let's step back for a moment and provide some background on why more research on nutritional status in pregnancy is needed.
At Needed, our work is driven by science and clinical insights - and with that we align with an approach to meeting nutritional needs that starts with a healthy, balanced diet. We also recognize that for most pregnant women it is challenging to meet nutritional recommendations with diet alone – especially given that their nutritional needs are increased and many women enter this phase of life nutritionally depleted. Relatedly, many major health organizations recommend that pregnant women take a daily prenatal vitamin. However, an emphasis on optimizing nutrition in standard of care for women’s health across the lifespan is lacking. This has created a complex landscape for women and their care providers to navigate where most prenatal vitamins are dosed to reflect the daily recommendations for specific nutrients like folate and iron, but vary widely in dose and/or form of many key nutrients for pregnancy. Therefore, most common prenatal vitamins are not nutritionally optimized to align with contemporary evidence or to fill dietary gaps for women in this life stage.
Further, research suggests that nutrient depletion is widespread, especially among women of reproductive age, even with a prenatal vitamin. These issues are heightened by the historical underrepresentation of women (especially pregnant and lactating women) in health and medical research, including research which informed our current dietary recommendations for pregnancy. Taken together, a picture of the state of prenatal nutrition begins to crystalize, with many gaps still existing in our current understanding of nutritional status and needs for this lifestage. A relentless pursuit of research and clinical insights is needed to improve our understanding of the state of prenatal nutrition and to ensure pregnant women receive optimized nourishment when it matters most!
So all this said – Lets break down our first IRB approved study, from why we conducted the study to some key findings.
Why did we conduct this study?
Evidence suggests that many US women do not meet nutritional recommendations for pregnancy, even with prenatal supplementation. Yet, (1) a focus on nutritional assessment and optimization in perinatal standard care is lacking and (2) there remains a lack of data regarding micronutrient status of pregnant US women from robust biochemical status assessments (i.e., blood nutrient concentrations).
This Prenatal Nutrient Status Study set out to help address the knowledge gap which exists regarding objective nutritional status data in pregnant US women. Our primary objective was to assess the nutritional status of pregnant women taking a ‘standard’ folic-acid containing prenatal vitamin. These commonly used prenatal supplements are typically formulated to meet basic recommendations for certain nutrients, but may fall short in key nutrients evidenced to support optimal health in pregnancy. Additionally, “standard prenatal” vitamins are those which are most often recommended by providers and purchased in this life stage, and therefore represent what many US women are receiving.
As part of this study, we also enrolled a sample of pregnant women taking the Needed Prenatal Multis, with the aim of exploring whether micronutrient status differs by the type of prenatal vitamin used in the current pregnancy. Below, we share some key findings from this aspect of the study.
Study Design
Given our main goal was to assess nutritional status among pregnant women taking a Standard Prenatal vitamin, we conducted an observational, cross-sectional, decentralized study to address this objective. This is a mouthful, but it means we collected data over a short period of time, without applying an intervention, and participants were able to complete all the research activities at their home or convenient locations (rather than a traditional clinical research site, such as a university).
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This study was approved by an outside, independent Institutional Review Board (IRB), a group with appropriate expertise who review and monitor research involving human subjects. They have the ability to approve or disapprove research, making IRB approval key to upholding the protection of human participants and maintaining public trust in scientific advancements.
Who did we recruit as participants?
We enrolled adult pregnant women 18+ years of age in this study who were:
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Weeks 24-34 of pregnancy
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Taking a prenatal vitamin (either a Standard Prenatal or a Needed Prenatal Multi)
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Living in or near one of seven metropolitan areas in the US (Atlanta, Chicago, Denver, Houston, Las Vegas, Los Angeles, or Philadelphia)
What data did we collect and analyze?
We collected survey data and biological markers measured in the blood which indicate nutritional intake and status (known as nutritional biomarkers) in adult pregnant women across the US.
How many participants did we analyze for this study?
235 Women were included in the study analysis
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212 women taking a Standard Prenatal
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23 women taking a Needed Prenatal Multi users
What did we find?
We found that the study groups (Standard prenatal and Needed Prenatal Multi groups) were comparable on a number of key maternal characteristics!
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Both groups had an average age of about ~32 years.
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Our participants were also spread across the US, living in or near 7 cities (Atlanta, Chicago, Denver, Houston, Las Vegas, Los Angeles, or Philadelphia).
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54% of women in the Standard Prenatal group, and 35% of women in the Needed Prenatal Multi group identified as a race/ethnicity other than “White-only”, highlighting the racial-ethnic diversity of the study participants.
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In the Standard Prenatal group, 47% and 53% of women were in the 2nd and 3rd trimesters of pregnancy, respectively. In the Needed Prenatal Multi group 61% and 39% of women were in the 2nd and 3rd trimesters of pregnancy, respectively.
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65% of women in the Standard group and 83% of women in the Needed Prenatal Multi group reported an annual income > $70,000.
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92% of women in the Standard Prenatal group reported seeing a OBGYN for prenatal care (76% ONLY seeing OBGYN vs. another provider such as a midwife), vs 70% in the Needed Prenatal Multi group (52% ONLY seeing OBGYN vs. another provider such as a midwife).
Did nutritional status differ between women taking a Standard Prenatal vs. women taking the Needed Prenatal Multi?
Our findings were pretty striking and center around 4 major nutrients for pregnancy – Vitamin D, Vitamin B6, Selenium, and Zinc.
Women taking a Needed Prenatal Multi also had significantly higher blood levels of multiple key nutrients for pregnancy including vitamin D, vitamin B6, Riboflavin, vitamin B12, vitamin K2, and selenium, compared to the women taking the standard prenatal.✝ Now, we recognize that higher or more does not always mean better, and we were also mindful of healthy lower and upper levels for nutrients. With this, the group of women taking the Needed Prenatal Multi fell within reference ranges for these nutrients.
Additionally, when we compared levels of nutrients in the blood in each prenatal vitamin group, we found that only the women in the Needed Prenatal Multi group fell within sufficient ranges for Vitamin D (>40 ng/mL) and Vitamin B6 (>5 ng/mL).✝ This result means that the Standard group levels of both vitamins fell below sufficient ranges for these nutrients.
Finally, we found that there was a relationship between the type of prenatal vitamin women were taking and nutritional status of vitamin D, vitamin B6, selenium, and zinc. A significantly greater proportion of women in the standard prenatal group had blood levels of all four nutrients which fell below sufficient ranges for pregnancy, compared to women taking a Needed Prenatal Multi.
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65% (majority) of women taking a standard prenatal fell below sufficient ranges for Vitamin D
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Vs only 30% of women taking a Needed Prenatal Multi
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66% (majority) of women taking a standard prenatal fell below sufficient ranges for Vitamin B6
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Vs only 22% of women taking a Needed Prenatal Multi
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18% (nearly one in five) of women taking a standard prenatal fell below sufficient ranges for Zinc
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Vs 0% of women taking a Needed Prenatal Multi
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35% (more than one in three) of women taking a standard prenatal fell below sufficient ranges for Selenium
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Vs 0% of women taking a Needed Prenatal Multi
With this, it’s important to note that we found no statistically significant differences in folate status between the Needed Prenatal Multi and Standard (folic acid-containing) Prenatal groups.✝ This finding contributes to the overall evidence that pregnant women taking the active form of folate, L-methylfolate, achieve comparable folate levels to women taking folic acid. This is key, given folate’s role in supporting neural tube development.
Why is this research important for advancing women’s health?
Prenatal supplements are designed to fill nutritional gaps in the diet. However, current data suggests that pregnant American women are not meeting nutritional recommendations, even with a prenatal supplement. Yet, assessments of nutritional status in pregnancy and an emphasis on nutrition for this life stage, have been historically lacking. As part of this study, we found that the type of prenatal vitamin women were taking was related to the status of Vitamin D, Vitamin B6, Selenium, and Zinc. Our results indicated that a higher proportion of women in the Standard Prenatal group fell below sufficient ranges for blood levels of these nutrients, compared to women taking the Needed Prenatal Multi. This study adds to the growing evidence that many standard prenatal vitamins may not be optimized to meet the nutritional needs of pregnant women.
We invested in this important research to better understand the state of prenatal nutrition among women taking prenatal vitamins, using objective markers in the blood as indicators of nutritional status. This study is an exciting first step towards the future of nutrition research at Needed!
What are the next steps for this research?
We value the trust in quality and rigor that stems from the peer-reviewed publication process (review and approval of a study by experts in the field before publication).
We have shared some preliminary highlights from this study regarding comparative analyses of nutrient status measures between groups of pregnant women taking different types of prenatal vitamins (a 'standard' Prenatal vs. the Needed Prenatal Multi) and provided some details on the study to make our approach accessible to customers–regardless of their scientific background.
With this, publication remains a critical next step on our research roadmap. This observational, cross-sectional, decentralized, clinical research study collected a robust set of meaningful health and nutrition-related data points in a diverse group of pregnant women living across the US. Therefore, we are planning for multiple publications stemming from the data collected in this study. As mentioned, this study set out to assess nutritional status among pregnant women taking a ‘standard’ folic-acid containing prenatal vitamin. As part of this study, we also enrolled a sample of pregnant women taking the Needed Prenatal Multi, with the aim of exploring whether micronutrient status differed by the type of prenatal vitamin consumed during the current pregnancy. Our publication trajectory will begin with submitting our primary study findings to an academic journal and presenting this data at scientific conferences.
Our first publication from this study is currently in submission at an academic journal and we are presenting our first accepted abstract on this study at the upcoming American Society for Nutrition (ASN NUTRITION 2025) conference. We are excited to put our study approach and findings through the rigorous peer review process and to highlight the trajectory of this contribution to women’s health research through future publications.
We presented our first accepted abstract from this study at NUTRITION 2025, the American Society for Nutrition’s annual conference—one of the leading scientific gatherings in the field of nutrition. We were also selected to present a poster highlighting findings from this study at the 2025 NIH Workshop on Prenatal Dietary Supplements: Evidence Gaps and Research Needs, held on NIH’s main campus. Our first publication from this study is also currently in submission at an academic journal. We are excited to put our study approach and findings through the rigorous peer review process and to highlight the trajectory of this contribution to women’s health research through future publications. We know this process takes time, but it's worth the wait!
✝These group level comparisons were based on median blood serum levels of micronutrients.
Based on our Prenatal Nutrient Status Study, an observational cross-sectional decentralized clinical research study which analyzed nutritional biomarkers among 235 pregnant women in the US. Data on file.
This study was funded by Rise Together Ventures and Needed PBC.
