We just completed our first *IRB approved study through Needed Labs to examine nutritional characteristics in pregnant women and the results are striking!
*IRB - Institutional Review Board.
Summary of the Science
At our core, Needed is committed to a higher standard of research-backed and expert-vetted supplements designed to combat nutritional depletion. Our commitment to constant improvement through investments in scientific advancements and clinical insights led to the birth of Needed Labs. We know that research has the power to change minds and care paradigms. Needed Labs is on a mission to uncover new data through research and aggregate clinical insights to make sure:
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That the impact of proper perinatal nutrition can no longer be ignored in the standard of care
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Knowledge around perinatal nutrition advances to exist at the cutting edge
Investing in perinatal nutrition research is core to our approach at Needed and aligns with our commitment to provide Unrivaled Nutrition for Fertility, Pregnancy and Postpartum – in support of women’s health and the health of future generations That’s why our first clinical research study is so important.
Research suggests that up to 95% of women experience nutritional depletion, even with a prenatal vitamin.
While the importance of maternal nutrition to support the health of women and future generations is well accepted by perinatal health experts, an emphasis on optimizing nutrition in standard of care for women’s health across the lifespan is lacking. Complicating matters further, common prenatal vitamins are formulated to meet recommendations for nutrients like folate and iron, but lack inclusion of optimal forms and/or doses of these and other key nutrients for pregnancy which are backed by modern evidence. With this, many women receive little nutritional advice (in this study we found that nearly 80% of women reported receiving little to no nutritional advice from their OBGYN) and are left to do their own nutritional research in a category that’s crowded with misinformation.
We need more evidence to better understand the current state of prenatal nutrition and whether there are differences in nutritional status among women taking differing prenatal vitamins. So, we invested in a clinical research study to help us begin to address this important question.
We studied 235 pregnant women living across the US, and compared blood levels of nutrients (indicators of nutrient status!) by the type of prenatal they were taking — the ‘Needed Prenatal Multi Supplement group’ vs the ‘Standard Prenatal group’. The “standard prenatal” was defined in this study as a folic-acid containing prenatal vitamin, as this type is typically consumed by women in the US.
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Women taking the Needed Multi Prenatal had significantly higher blood levels of key nutrients for pregnancy including vitamin D, vitamin B6, Riboflavin, vitamin B12, vitamin K2, and selenium, compared to the women taking the standard prenatal.
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Only the group of women taking the Needed Multi Prenatal fell within sufficient ranges for Vitamin D (>40 ng/mL) and Vitamin B6 (>5 ng/mL).
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Our results also indicated that the Standard Prenatal group had a significantly higher percentage of women falling below sufficient ranges for blood levels of Vitamin D, Vitamin B6, Selenium, and Zinc, compared to women taking the Needed Multi Prenatal.
This study contributes to the evidence which suggests that the standard prenatal vitamin is not cutting it.
For the scientifically curious - let’s get into the nitty gritty 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 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. Unfortunately, even with piles of research highlighting benefits of several nutrients for maternal and infant health outcomes, universally agreed-upon recommendations are lacking in terms of nutrient profiles, doses, and forms for prenatal supplements. This has created a complex landscape for women and their care providers to navigate where most prenatal vitamins are dosed to reflect the daily requirements for specific nutrients like folate and iron, with inconsistent inclusion of other key nutrients. 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.
Unsurprisingly, research suggests that nutrient depletion is widespread, especially among women of reproductive age, even with a prenatal vitamin. For example, it is estimated that the majority of pregnant women have inadequate intakes of nutrients like vitamin D, and these shortfalls remain despite taking 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 what we found.
Why Did We Conduct This Study?
As part of our study, we set out to examine key nutritional status characteristics in pregnant women based on the type of prenatal vitamin they were taking:
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‘Standard Prenatal’ supplement or Needed Multi Prenatal supplement.
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So, when we say “prenatal supplement groups” in this article, we simply mean women were either in the group taking a Standard Prenatal or a Needed Multi prenatal, because we analyzed differences between these groups overall.
How Did We Define a “Standard Prenatal” For This Study?
“Standard Prenatal” was defined as a prenatal supplement containing folic acid, rather than another form of folate like methylfolate. We chose folic acid containing prenatals as the “standard prenatal” given these common prenatals are often formulated to meet daily recommendations for specific nutrients like folate and iron, but tend to lack optimal forms and doses of other key nutrients for pregnancy like vitamin D, choline, and selenium.
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.
Study Design
We conducted an observational, cross-sectional, decentralized study. 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 trial was approved by an 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 Multi Prenatal)
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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, and What Were Our Main Objectives?
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. The measurement of nutrient levels in the blood is a key aspect of nutritional status assessment. We collectively evaluated the existing nutrition research, clinical insights of practitioners, and laboratory-reported healthy reference ranges to evaluate the blood levels of nutrients which are considered “sufficient” in pregnancy.
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With all this data at hand, we had a key questions we wanted to answer:
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(1) Were there differences in blood levels of nutrients (indicators of nutrient status!) between the groups of women taking a Standard Prenatal and the Needed Multi Prenatal?
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Where did the blood levels of nutrients in each prenatal group fall, relative to the thresholds for “sufficiency”?
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(2) Was the type of prenatal vitamin women were taking (Standard Prenatal vs Needed Multi Prenatal) related to nutrient status?
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 Multi Prenatal users
So Now That You Have All of this Background on the Study, I’m Sure You’re Wondering – What Did the Study Find?
First, we looked at the demographic and pregnancy characteristics of the women in each prenatal group to get a sense of who our participants were and whether groups were similar on certain characteristics. We found that the study groups (Standard prenatal and Needed Multi Prenatal 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 Multi Prenatal 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 Multi Prenatal group 61% and 39% of women were in the 2nd and 3rd trimesters of pregnancy, respectively.
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65% of Standard group and 83% in the Needed Multi Prenatal group reported income > $70,000
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92% of Standard Prenatal group reported seeing a OBGYN for prenatal care (76% ONLY seeing OBGYN vs another provider such as a midwife), vs 70% in Needed Multi Prenatal group (52% ONLY seeing OBGYN vs another provider such as a midwife)
Now for the main event – did nutritional status differ among women taking a Standard Prenatal vs. women taking the Needed Multi Prenatal?
As a refresher here’s how we assessed and compared nutritional status between groups:
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Compared blood levels of micronutrients between groups
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Analyzed whether or not blood concentrations of nutrients in each group fell within sufficient ranges for pregnancy
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Assessed the proportions of women who fell below sufficient blood ranges for nutrients in each group, and analyzed whether there was a relationship between the type of prenatal vitamin women were taking and having suboptimal levels of nutrients measured.
*These group level comparisons were based on median blood serum levels of micronutrients.
Our main findings were pretty striking and center around 4 major nutrients for pregnancy – Vitamin D, Vitamin B6, Selenium, and Zinc – so without further ado, let's get into it:
To start, women taking a Needed Multi prenatal 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 Multi Prenatal fell within healthy 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 Multi Prenatal 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.
And – while this is compelling, there’s more! We also found that there was a relationship between the category of prenatal vitamin women were taking and nutritional status of vitamins D, 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 Multi Prenatal.
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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 Multi Prenatal
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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 Multi Prenatal
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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 Multi Prenatal
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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 Multi Prenatal
Importantly, we also found that factors like diet and how often women took their prenatal vitamins did not impact our results. Additionally, while we are highlighting key findings of the study here, it is important to note that of all nutrient biomarkers assessed – none statistically favored the Standard Prenatal group.
Why Are These Findings Important?
Prenatal supplements are designed to fill nutritional gaps in the diet. However, current data suggests that up to 95% of women experience nutritional depletion, even with a prenatal vitamin. In the landscape of depleting factors and increased nutritional needs of pregnancy, common prenatals are not optimized in nutrient profiles, doses, and forms to support women’s needs. However, objective assessments of nutritional status in pregnancy and emphasis on nutrition for this life stage, have been historically lacking.
In this study, we compared nutritional characteristics of women taking a Standard Prenatal vs women taking a Needed Multi Prenatal and found that the type of prenatal women were taking was related to the status of Vitamin D, Vitamin B6, Selenium, and Zinc. Our results indicated that the Standard Prenatal group had a significantly higher percentage of women falling below sufficient ranges for blood levels of these nutrients, compared to women taking the Needed Multi Prenatal. This study contributes to the growing body of evidence to suggest that the standard prenatal vitamin is not cutting it.
We invested in this important research to better understand the state of prenatal nutrition among women taking different categories of 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!
*Results from an observational cross-sectional decentralized clinical research study. Data on file.
This study was funded by Needed PBC and Rise Together Ventures.
