Paternal folate intake associated with longer gestation
Folate is essential to the healthy development of babies in early pregnancy. It is recommended that women trying to conceive take 400 μg of folic acid to reduce the risk of neural tube defects.
New research from the University of Navarra, Spain, indicates that attention should also be given to the folic acid intake of potential fathers.
Nerea Martin-Calvo and her team prospectively analysed data from 108 heterosexual couples undergoing infertility treatment using their own gametes whose treatment resulted in 113 pregnancies between 2007 and 2017.
After accounting for factors like age, race, and mother’s folate intake, a 400 μg/day increase in preconception paternal folate intake was associated with a 2.6 day longer gestation (95% CI:0.8, 4.3) which is generally thought to be positive for the health of the baby. This association could not be made with maternal folate intake.
Check out the full study to find out more.
Regulation of Folic Acid
Folic acid, calcium folinate, levomefolate calcium, and levomefolate glucosamine are included in the Therapeutic Goods (Permissible Ingredients) Determination and can be used in listed medicines.
The TGA provides a fact sheet on the regulation of folate and folic acid when used in listed medicines.
When a medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 μg of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose.
The TGA has provided a restricted representation exemption for products containing at least 400 μg of folic acid and claiming to reduce the risk of neural tube defects.
Sponsors should note that when a product makes claims about reducing the risk of neural tube defects or spina bifida, the medicine must contain a warning that states “Warning: Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida – seek specific medical advice” or words to that effect.
If you need help with meeting your regulatory obligations, don’t hesitate to get in touch with us. We can provide all these services and more!