FullWell study targets longstanding prenatal folate question

BOSTON — FullWell has launched an independent clinical study comparing methylfolate and folic acid to assess their potential effects on folate biomarkers and reproductive outcomes.

The reproductive wellness company said the FAMILIES study, short for Folic Acid, Methylfolate & Infertility: Longitudinal Improvement & Experience Study, is a prospective, Institutional Review Board-approved study designed to isolate the folate form as a single variable.

Sponsored by FullWell and conducted by the independent research organization People Science Inc., the study will enroll 120 women across the United States, targeting 100 evaluable participants. Eligible participants are healthy women with male partners who have been trying to conceive naturally for less than six months and who have no diagnosed reproductive conditions.

Participants will be randomly assigned to receive one of two otherwise identical prenatal formulations. One will contain folate as 5-MTHF (methylfolate), while the other will contain folic acid.

Researchers will assess blood biomarkers, time to conception, conception rates, pregnancy progression, and participant-reported experiences over up to 72 weeks. The study is designed to follow participants from attempts to conceive through pregnancy and potentially into the postpartum period.

“The methylfolate versus folic acid question has been coming up for years. We created FAMILIES to answer that question head-on,” said Ayla Barmmer, MS, RD, LDN, founder of FullWell and designated lead author of the study. “This is the kind of research we believe women’s health deserves, and we’re committed to sharing the findings regardless of what they show.”

FullWell said the study addresses a lack of prospective research directly comparing the two forms of folate while tracking biological markers and fertility and pregnancy outcomes.

The study’s principal investigator is Azure Grant, Ph.D., of People Science, with Noah Craft, M.D., Ph.D., and Marie Crisel Erfe, M.D., serving as sub-investigators. FullWell said it plans to make the full findings available regardless of the study’s outcome.