Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)

Last updated: April 15, 2025
Sponsor: Ottawa Hospital Research Institute
Overall Status: Completed

Phase

N/A

Condition

Pregnancy Complications

Asthma

Asperger's Disorder

Treatment

SRS 2, CBCL, BRIEF-P

Clinical Study ID

NCT03269110
CTO 816
  • Ages 4-6
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

FACT 4 Child is a follow up study of mothers who participated in the Folic Acid Clinical Trial (NCT01355159) and their children at 4-6 years of age to determine the effect of high dose folic acid supplementation on social impairments associated with Autism Spectrum Disorders (ASDs), and deficiencies in a range of executive function and emotional and behavioural problems in young children, and the risk of death.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Capability of participant to comprehend and comply with study requirements

  2. Mother participated in FACT

Exclusion

Exclusion Criteria:

  1. Confirmed spontaneous termination (miscarriage) or elective termination or stillborn

  2. Confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital

Study Design

Total Participants: 664
Treatment Group(s): 1
Primary Treatment: SRS 2, CBCL, BRIEF-P
Phase:
Study Start date:
July 01, 2017
Estimated Completion Date:
December 31, 2023

Study Description

The Folic Acid Clinical Trial (FACT) was developed to conclusively determine the effect of high dose folic acid supplementation in pregnancy on the prevention of preeclampsia in a randomized controlled trial (RCT) design.

The primary objective of the FACT 4 Child study is to examine the effect of maternal folic acid supplementation in pregnancy on the risk of social impairments, as well as executive function, emotional and behavioural problems associated with Autism Spectrum Disorders (ASD) and other developmental disorders, and death in offspring aged 4-6 y of mothers recruited to the CIHR funded FACT.

The effect of folic acid supplementation throughout pregnancy may potentially have an impact on both the mother and her offspring, which highlights the importance and relevance of this study to the management of women with preeclampsia. Results of this study will allow care providers to have the evidence of potential effects of high dose folic acid that can then be discussed; allowing women to make an informed choice about their management and care.

Connect with a study center

  • Nepean

    Penrith, New South Wales 2750
    Australia

    Site Not Available

  • Townsville

    Douglas, Queensland 4814
    Australia

    Site Not Available

  • Ipswich

    Ipswich, Queensland 4305
    Australia

    Site Not Available

  • Women's and Children's Hospital

    Adelaide, South Australia
    Australia

    Site Not Available

  • Royal Women's

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Sunshine

    St Albans, Victoria 3021
    Australia

    Site Not Available

  • Calgary Foothills Medical Center

    Calgary, Alberta T2N2T9
    Canada

    Site Not Available

  • Edmonton Lois Hole Hospital for Women

    Edmonton, Alberta T5H 3V9
    Canada

    Site Not Available

  • St-Paul's Hospital

    Vancouver, British Columbia V6Z 2K5
    Canada

    Site Not Available

  • Winnipeg University of Manitoba

    Winnipeg, Manitoba R3E 3P4
    Canada

    Site Not Available

  • Fredericton Dr. Everett Chalmers Regional Hospital

    Fredericton, New Brunswick E3B 5N5
    Canada

    Site Not Available

  • Moncton Hospital

    Moncton, New Brunswick E1C 6Z8
    Canada

    Site Not Available

  • St-John's Women's Health Centre

    St John's, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • Hamilton McMaster University

    Hamilton, Ontario L8S 4K1
    Canada

    Site Not Available

  • Kingston

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • London

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • The Ottawa Hospital, Civic Campus

    Ottawa, Ontario K1Y 4E9
    Canada

    Site Not Available

  • The Ottawa Hospital, General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Sunnybrook Health Sciences

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Quebec City (CHUL) Centre Hospitalier Universitaire

    Montreal, Quebec G1V 4G2
    Canada

    Site Not Available

  • Sainte-Justine

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • St-Luc

    Montreal, Quebec
    Canada

    Site Not Available

  • St-Mary's Hospital

    Montreal, Quebec H3T 1M5
    Canada

    Site Not Available

  • Regina Qu'Appelle Health Region

    Regina, Saskatchewan S4P 0W5
    Canada

    Site Not Available

  • Jubilee

    Kingston,
    Jamaica

    Site Not Available

  • Spanishtown

    Kingston,
    Jamaica

    Site Not Available

  • University of West Indies

    Kingston 7,
    Jamaica

    Site Not Available

  • Hinchingbrooke

    Huntingdon, Cambridgeshire PE29 6NT
    United Kingdom

    Site Not Available

  • Leighton

    Crewe, Cheshire CW1 4QJ
    United Kingdom

    Site Not Available

  • Darlington Memorial Hospital

    Darlington, County Durham DL3 6HX
    United Kingdom

    Site Not Available

  • Fairfield

    Bury, Lancashire BL9 7TD
    United Kingdom

    Site Not Available

  • Rochdale

    Rochdale, Lancashire OL12 0NB
    United Kingdom

    Site Not Available

  • Lincolnshire

    Lincoln, Lincolnshire LN2 4AX
    United Kingdom

    Site Not Available

  • West Middlesex University Hospital

    Isleworth, Middlesex TW7 6AF
    United Kingdom

    Site Not Available

  • Wansbeck General Hospital

    Ashington, Northumberland NE63 9JJ
    United Kingdom

    Site Not Available

  • St George's Hospital

    London, Tooting SW17 0QT
    United Kingdom

    Site Not Available

  • Gateshead Queen Elizabeth Hospital

    Gateshead, Tyne And Wear NE9 6SX
    United Kingdom

    Site Not Available

  • South Tyneside Distrcit Hospital

    South Shields, Tyne And Wear NE34 0PL
    United Kingdom

    Site Not Available

  • Blackburn

    Blackburn, BB2 3HH
    United Kingdom

    Site Not Available

  • Burnley

    Burnley, BB10 2PQ
    United Kingdom

    Site Not Available

  • Cumberland Infirmary Carlisle

    Carlisle,
    United Kingdom

    Site Not Available

  • North Manchester

    Crumpsall, M8 5RB
    United Kingdom

    Site Not Available

  • North Durham

    Durham,
    United Kingdom

    Site Not Available

  • Guy's and St. Thomas

    London,
    United Kingdom

    Site Not Available

  • South Tees Hospital

    Middlesbrough, TS4 3BW
    United Kingdom

    Site Not Available

  • Newcastle upon Tyne Hospitals

    Newcastle upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • North Tyneside General Hospital

    North Shields, NE29 8NH
    United Kingdom

    Site Not Available

  • Norfolk & Norwich

    Norwich,
    United Kingdom

    Site Not Available

  • Nottingham City Hospital

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Nottingham Queens Medical Centre

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Oldham

    Oldham, OL1 2JH
    United Kingdom

    Site Not Available

  • North Tees Hospital

    Stockton, TS19 9AH
    United Kingdom

    Site Not Available

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP
    United Kingdom

    Site Not Available

  • Hillingdon Hospital

    Uxbridge, UB8 3NN
    United Kingdom

    Site Not Available

  • Warrington Hospital

    Warrington,
    United Kingdom

    Site Not Available

  • West Cumberland Hospital

    Whitehaven,
    United Kingdom

    Site Not Available

  • 49 Marine Avenue

    Whitley Bay,
    United Kingdom

    Site Not Available

  • Royal Wolverhampton - New Cross Hospital

    Wolverhampton,
    United Kingdom

    Site Not Available

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