Supplement company Ritual announced the publication of a 24-week clinical study comparing its prenatal formula, which contains the biologically active form of folate called 5-MTHF, versus a prenatal supplement containing synthetic folic acid in a population of 62 pregnant mothers. The findings of the trial, which was completed a year ago, were published in Frontiers in Nutrition.

 According to the findings, 5-MTHF supplementation maintained folate status just as effectively in maternal blood concentrations and in umbilical cord blood, but with significantly less unmetabolized folic acid in the body. Detectable concentrations of unmetabolized folic acid appeared in 7% of the 5-MTHF group versus 31% of the folic acid group.

Meanwhile, there were no differences in total folate levels between groups. The full prenatal formula also resulted in reductions in cortisol and a 2.4 increase in biotin levels, the authors noted.

The company noted that it is filling a critical research gap left by decades of inaction and the exclusion of pregnant women from clinical trials until 1993. Less than two percent of medical research funding is allocated to pregnancy and childbirth, the company noted.

In the clinical study, which was conducted in partnership with CUNY and Cornell, diversity was a non-negotiable, and 66% of participants identified as Black, Asian, or other non-white racial backgrounds.

“Women were routinely excluded from clinical trials until 1993, leaving many existing healthcare and nutrition recommendations based on data extrapolated from studies conducted on men. This has made it more difficult to understand the unique needs and hormonal changes experienced by women, especially during pregnancy,” the company reported. “The exclusion of pregnant women, particularly those from diverse racial and ethnic backgrounds, has furthered this significant gap in maternal health research. A lack of inclusivity leads to a shortage of robust, evidence-based guidance for pregnant women’s care and treatment, leaving many products and recommendations inadequately tested for safety and efficacy.”

The company has committed to investing $5 million to conduct clinical studies on its entire product portfolio.