None listed
Conditions
Brief summary
A decentralised, single-centre, randomised, controlled, clinician, researcher and participant blinded trial with two parallel groups conducted in all states and territories in Australia to determine the effect of removing folic acid from vitamin and mineral supplements for pregnant and lactating women. The study aims to investigate and evaluate the risks and benefits of continued folic acid supplementation so that both mothers and policymakers can make informed decisions during pregnancy.
Interventions
Intervention combination product - no folic acid supplement prenatal vitamin and mineral supplement.
Folic acid 0 µg; Beta carotene (All trans-beta- carotene) 2500 IU; Vitamin E (dl-alphatocopheryl acetate) 13.5 mg AT; Vitamin D3 (cholecalciferol) 10 µg; Vitamin C (ascorbic acid granular) 85 mg; Niacinamide 18 mg; Pantothenic acid (calcium d- pantothenate) 6 mg; Vitamin B6 (DC pyridoxine hydrochloride) 1.9 mg; Vitamin B1 (thiamine mononitrate) 1.4 mg; Vitamin B2 (riboflavin) 1.4 mg; Biotin 30 µ
Intervention combination product - no folic acid supplement prenatal vitamin and mineral supplement. Folic acid 0 µg; Beta carotene (All trans-beta- carotene) 2500 IU; Vitamin E (dl-alphatocopheryl acetate) 13.5 mg AT; Vitamin D3 (cholecalciferol) 10 µg; Vitamin C (ascorbic acid granular) 85 mg; Niacinamide 18 mg; Pantothenic acid (calcium d- pantothenate) 6 mg; Vitamin B6 (DC pyridoxine hydrochloride) 1.9 mg; Vitamin B1 (thiamine mononitrate) 1.4 mg; Vitamin B2 (riboflavin) 1.4 mg; Biotin 30 µg; Vitamin B12 (methyl-cobalamin) 5.0 µg; Iodine 0.15 mg; Calcium (carbonate DC) 250 mg; Magnesium (oxide granular) 50 mg; Iron (ferrous fumarate) 10 mg; Zinc (oxide) 5 mg; Manganese (sulphate) 2 mg; Copper (sulphate) 1 mg; Selenomethionine 30 µg. Single oral capsule containing vitamin and mineral supplement doses, taken once per day from enrolment (between 12+0 and 15+6 weeks gestation) until the baby is three months of age. During pregnancy follow up, participants will be asked how many study supplements they have taken in the past week. Start date and stop date of study supplements will also be obtained via maternal report.
Sponsors
South Australian Health and Medical Research Institute (SAHMRI)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pregnant women between 11+0 and 15+6 weeks gestation; 2. Currently taking, have taken, or intending to take a folate containing supplement during the first trimester of this current pregnancy; 3. Willing to cease all current folate containing supplements; 4. Able to give written informed consent.
Exclusion criteria
1. Existing diagnosis of Type I, Type II, or Gestational diabetes (in this current pregnancy); 2. Previous randomisation in the FIG study with a previous pregnancy; 3. Carrying a foetus with a confirmed or suspected fetal abnormality; 4. Currently taking medication known to interfere with folate metabolism (i.e. anticonvulsant, anti-malaria medication, or barbiturates); 5. Intolerance, known allergy, or contraindication (e.g. hyperthyroidism) to any ingredient contained within the study supplement. 6. Active inflammatory bowel disease or other pre-existing chronic malabsoption disorders such as Crohn's disease or ulcerative colitis (not including coeliac disease or lactase intolerance)
Outcome results
None listed