Does stopping folic acid at 12 weeks of pregnancy reduce the amount of unmetabolised folic acid in the blood of pregnant women - The Folic Acid in Pregnancy Study

INTERVENTION: Participants will be randomised to receive either a prenatal micronutrient supplement containing 0.8 mg folic acid (Control) or an identical micronutrient supplement containing no folic acid (Intervention). The composition of micronutrients within the intervention and control supplements are formulated to approximate the current leading brands of prenatal micronutrient supplements and both contain the following: calcium 250 mg, Iron 27 mg, thiamine 1.4 mg, riboflavin 1.4 mg, niacinamide 18 mg, vitamin B‐6 1.9 mg, vitamin B‐12 2.6 mcg, pantothenic acid 6 mg, biotin 30 mg, vitamin C 85 mg, vitamin E 13.5 IU, magnesium 50 mg, zinc 7.5 mg, manganese 2.0 mg, iodine 0.22 mg, copper 1 mg, chromium 30 mcg, selenium 30 mcg, Vitamin D3 10 mcg, b‐carotene 2500 IU. Intervention and control supplements will be in tablet form and are identical in size, shape, colour and packaging. They only differ in the removal of folic acid from the intervention supplement. Study supplements will be packaged and labelled in accordance with the Code of Good Manufacturing Practice (GMP) for Medicinal Products and Therapeutic Goods Administration (TGA) guidelines for clinical trial products, including; product identification number (Product ID), batch number, expiry date and include the statement “for clinical trial use onlyâ€?. The intervention and control supplements will be manufactured and donated by Factors Group of Companies, Coquitlam, British Columbia, Canada. Participants will be supplied with supplements for the duration of their pregnancy. The initial supply will be dispensed following randomisation and enough supplements will be given to last until the 36 week clinic visit as well as additional supplements as a compliance measure. At the 36 week clinic visit, participants will then be issued with supplements to last the reminder of their pregnancy. The study supplements are ready to administer requiring no preparation. Participants will be instructed to take one sup CONDITION: Folic acid supplementation in late gestation; ; Folic acid supplementation in late gestation Metabolic and Endocrine ‐ Normal metabolism and endocrine development and function PRIMARY OUTCOME: Maternal plasma unmetabolised folic acid concentrations between groups[36 weeks gestation] SECONDARY OUTCOME: Maternal plasma folate levels. ; [36 weeks gestation] Maternal red blood cell folate levels.[36 weeks gestation.] INCLUSION CRITERIA: To be eligible for participation women must meet all of the following criteria; 1) a singleton pregnancy greater or equal to 12 weeks and less than 16 weeks gestation. 2) currently taking a folic acid containing supplement and planning to continue throughout pregnancy. 3) be able to give informed consent.