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Trial registered on ANZCTR


Registration number
ACTRN12624000307505p
Ethics application status
Submitted, not yet approved
Date submitted
20/12/2023
Date registered
22/03/2024
Date last updated
22/03/2024
Date data sharing statement initially provided
22/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Folic Acid in Gestation Study.
Scientific title
Does continuing folic acid supplementation after the first trimester alter the risk of gestational diabetes mellitus: a randomised controlled trial.
Secondary ID [1] 311201 0
Optimising Prenatal Folic Acid Supplementation to Promote Best Outcomes for Mum and Child.
Secondary ID [2] 311361 0
The Folic Acid in Gestation Study
Universal Trial Number (UTN)
Trial acronym
The FIG Study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes 332377 0
Preconception health and wellbeing 332378 0
Pregnancy health and wellbeing 332604 0
Perinatal health and wellbeing 332605 0
Condition category
Condition code
Reproductive Health and Childbirth 329089 329089 0 0
Fetal medicine and complications of pregnancy
Diet and Nutrition 329090 329090 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327651 0
Prevention
Comparator / control treatment
Control combination product - folic acid supplement prenatal vitamin and mineral supplement.

Folic acid 500 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.
Control group
Active

Outcomes
Primary outcome [1] 337123 0
Diagnosis of gestational diabetes mellitus.
Timepoint [1] 337123 0
At mid-pregnancy (approx. 26-28 weeks gestation).
Secondary outcome [1] 430128 0
Maternal pregnancy complications, including pre-eclampsia, spontaneous or induction of labour, reason for induction (if applicable), haemorrhage, mode of delivery.
Timepoint [1] 430128 0
Birth.
Secondary outcome [2] 430129 0
Length of gestation.
Timepoint [2] 430129 0
Birth.
Secondary outcome [3] 430130 0
Infant Birth Weight
Timepoint [3] 430130 0
Birth.
Secondary outcome [4] 430787 0
Infant Birth Length
Timepoint [4] 430787 0
Birth
Secondary outcome [5] 430788 0
Infant Birth Head Circumference
Timepoint [5] 430788 0
Birth
Secondary outcome [6] 430789 0
Admission to special care baby unit (level 2 nursery).
Timepoint [6] 430789 0
The neonatal period including birth to 28 days of age.
Secondary outcome [7] 430790 0
Post natal depression diagnosis
Timepoint [7] 430790 0
From birth until 6 months of age.
Secondary outcome [8] 430791 0
Infant allergy diagnosis
Timepoint [8] 430791 0
From birth until 12 months of age.
Secondary outcome [9] 430792 0
Admission to neonatal intensive care unit (NICU)
Timepoint [9] 430792 0
From birth until 2 years of age
Secondary outcome [10] 430793 0
Infant developmental assessment of communication, gross motor, fine motor, problem solving, and personal-social skills.
Timepoint [10] 430793 0
12 months of age
Secondary outcome [11] 430794 0
Health service utilization.
Timepoint [11] 430794 0
From birth until 3 years of age.
Secondary outcome [12] 430857 0
Post natal depression diagnosis
Timepoint [12] 430857 0
From birth until 6 months of age.

Eligibility
Key inclusion criteria
1. Pregnant women between 12+0 and 15+6 weeks gestation;
2. Currently taking, or have taken, a folate containing supplement during the first trimester of this current pregnancy;
3. Willing to cease all current folate containing supplements;
3. Able to give written informed consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 or known allergy to prenatal vitamin and minteral supplement.
6. At increased risk of folate deficiency, including those with acquired or inherited haemolytic anaemia, inherited homocystinuria, haemoglobinopathy, malabsorption disorders (i.e. inflammatory bowel disease, Crohn’s, Ulcerative Colitis, short gut syndrome, previous bariatric surgery)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by a computerised randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2028
Actual
Date of last data collection
Anticipated
30/06/2031
Actual
Sample size
Target
2826
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315461 0
Charities/Societies/Foundations
Name [1] 315461 0
Women's and Children's Hospital Foundation
Country [1] 315461 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute (SAHMRI)
Address
North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 317532 0
None
Name [1] 317532 0
Address [1] 317532 0
Country [1] 317532 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314369 0
Women's and Children's Health Network
Ethics committee address [1] 314369 0
72 King William Road, North Adelaide, SA 5006
Ethics committee country [1] 314369 0
Australia
Date submitted for ethics approval [1] 314369 0
25/01/2024
Approval date [1] 314369 0
Ethics approval number [1] 314369 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131334 0
Prof Tim Green
Address 131334 0
SAHMRI, Level 7 Zone B, 72 King William Road, North Adelaide, SA 5006
Country 131334 0
Australia
Phone 131334 0
+61452 448 438
Fax 131334 0
Email 131334 0
tgreen@flinders.edu.au
Contact person for public queries
Name 131335 0
Ms Brooke Spencer
Address 131335 0
SAHMRI, Level 7 Zone B, 72 King William Road, North Adelaide, SA 5006
Country 131335 0
Australia
Phone 131335 0
+618 8128 4436
Fax 131335 0
Email 131335 0
brooke.spencer@sahmri.com
Contact person for scientific queries
Name 131336 0
Prof Tim Green
Address 131336 0
SAHMRI, Level 7 Zone B, 72 King William Road, North Adelaide, SA 5006
Country 131336 0
Australia
Phone 131336 0
+61452 448 438
Fax 131336 0
Email 131336 0
tgreen@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data may be shared after de-identification upon reasonable request.
When will data be available (start and end dates)?
From publication of results to 5 years after publication.
Available to whom?
To gain access, data requestors will need to sign a data access agreement. Proposals to access the data must be scientifically and methodologically sound and must be reviewed and approved by the Steering Committee and a certified paediatric Human Research Ethics Committee, recognised under the National Mutual Acceptance (NMA) scheme.
Available for what types of analyses?
Proposals to access the data must be scientifically and methodologically sound and must be reviewed and approved by the Steering Committee and a certified paediatric Human Research Ethics Committee, recognised under the National Mutual Acceptance (NMA) scheme. The data must only be used for the analyses detailed in the aims of the approved proposal.
How or where can data be obtained?
Proposals should be directed to Professor Tim Green, Principal Investigator; tgreen@flinders.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21245Study protocol    Details to be added when available.



Results publications and other study-related documents

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