--- title: "Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)" nct_id: NCT03269110 overall_status: COMPLETED sponsor: Ottawa Hospital Research Institute study_type: OBSERVATIONAL primary_condition: Autism Spectrum Disorder countries: Australia, Canada, Jamaica, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03269110.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03269110" ct_last_update_post_date: 2025-04-18 last_seen_at: "2026-05-12T06:54:30.885Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child) **NCT ID:** [NCT03269110](https://clinicaltrials.gov/study/NCT03269110) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 664 - **Lead Sponsor:** Ottawa Hospital Research Institute - **Conditions:** Autism Spectrum Disorder, Asthma, Executive Dysfunction, Emotional Problem, Behavioural Problem, Pre-Eclampsia, Death - **Start Date:** 2017-07-01 - **Completion Date:** 2023-12-31 - **CT.gov Last Update:** 2025-04-18 ## Brief 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. ## Detailed 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. ## Eligibility - **Minimum age:** 4 Years - **Maximum age:** 6 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` Inclusion Criteria: 1. Capability of participant to comprehend and comply with study requirements 2. Mother participated in FACT 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 ``` ## Arms - **Mother and child(ren)** — FACT 4 Child is the post-delivery follow-up of the offspring born to FACT mothers once these children are between the age of 4 - 6 years. ## Interventions - **SRS 2, CBCL, BRIEF-P** (DIAGNOSTIC_TEST) — This study does not involve an intervention. ## Primary Outcomes - **Neurocognitive disability** _(time frame: From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.)_ — The primary outcome is a competing composite endpoint of neurocognitive disability and death. Neurocognitive disability is a composite outcome related to social impairments, executive function, emotional and behavioural problems which have been associated with Autism Spectrum Disorder (ASD). It will be defined by an abnormal score on any of three standardized and validated assessment tools: SRS-2 BRIEF-P, or CBCL which will be administered to the parents of children aged 4-6 years. Deaths reported between 6 weeks to 4-6 years of age will be recorded as a competing event and treated as part of the primary endpoint. ## Secondary Outcomes - **Severe Morbidity** _(time frame: From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.)_ ## Locations (58) - Nepean, Penrith, New South Wales, Australia - Townsville, Douglas, Queensland, Australia - Ipswich, Ipswich, Queensland, Australia - Women's and Children's Hospital, Adelaide, South Australia, Australia - Royal Women's, Parkville, Victoria, Australia - Sunshine, St Albans, Victoria, Australia - Calgary Foothills Medical Center, Calgary, Alberta, Canada - Edmonton Lois Hole Hospital for Women, Edmonton, Alberta, Canada - St-Paul's Hospital, Vancouver, British Columbia, Canada - Winnipeg University of Manitoba, Winnipeg, Manitoba, Canada - Fredericton Dr. Everett Chalmers Regional Hospital, Fredericton, New Brunswick, Canada - Moncton Hospital, Moncton, New Brunswick, Canada - St-John's Women's Health Centre, St. John's, Newfoundland and Labrador, Canada - Hamilton McMaster University, Hamilton, Ontario, Canada - Kingston, Kingston, Ontario, Canada - London, London, Ontario, Canada - The Ottawa Hospital, General Campus, Ottawa, Ontario, Canada - The Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada - Sunnybrook Health Sciences, Toronto, Ontario, Canada - Quebec City (CHUL) Centre Hospitalier Universitaire, Montreal, Quebec, Canada - Sainte-Justine, Montreal, Quebec, Canada - St-Mary's Hospital, Montreal, Quebec, Canada - St-Luc, Montreal, Quebec, Canada - Regina Qu'Appelle Health Region, Regina, Saskatchewan, Canada - Jubilee, Kingston, Jamaica - Spanishtown, Kingston, Jamaica - University of West Indies, Kingston, Jamaica - Hinchingbrooke, Huntingdon, Cambridgeshire, United Kingdom - Leighton, Crewe, Cheshire, United Kingdom - Darlington Memorial Hospital, Darlington, County Durham, United Kingdom - Fairfield, Bury, Lancashire, United Kingdom - Rochdale, Rochdale, Lancashire, United Kingdom - Lincolnshire, Lincoln, Lincolnshire, United Kingdom - West Middlesex University Hospital, Isleworth, Middlesex, United Kingdom - Wansbeck General Hospital, Ashington, Northumberland, United Kingdom - St George's Hospital, London, Tooting, United Kingdom - Gateshead Queen Elizabeth Hospital, Gateshead, Tyne and Wear, United Kingdom - South Tyneside Distrcit Hospital, South Shields, Tyne and Wear, United Kingdom - Blackburn, Blackburn, United Kingdom - Burnley, Burnley, United Kingdom - Cumberland Infirmary Carlisle, Carlisle, United Kingdom - North Manchester, Crumpsall, United Kingdom - North Durham, Durham, United Kingdom - Guy's and St. Thomas, London, United Kingdom - South Tees Hospital, Middlesbrough, United Kingdom - Newcastle upon Tyne Hospitals, Newcastle upon Tyne, United Kingdom - North Tyneside General Hospital, North Shields, United Kingdom - Norfolk & Norwich, Norwich, United Kingdom - Nottingham City Hospital, Nottingham, United Kingdom - Nottingham Queens Medical Centre, Nottingham, United Kingdom - Oldham, Oldham, United Kingdom - North Tees Hospital, Stockton, United Kingdom - Sunderland Royal Hospital, Sunderland, United Kingdom - Hillingdon Hospital, Uxbridge, United Kingdom - Warrington Hospital, Warrington, United Kingdom - West Cumberland Hospital, Whitehaven, United Kingdom - 49 Marine Avenue, Whitley Bay, United Kingdom - Royal Wolverhampton - New Cross Hospital, Wolverhampton, United Kingdom ## Recent Field Changes (last 30 days) - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.university of west indies|kingston||jamaica` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.nepean|penrith|new south wales|australia` — added _(2026-05-12)_ - `locations.townsville|douglas|queensland|australia` — added _(2026-05-12)_ - `locations.ipswich|ipswich|queensland|australia` — added _(2026-05-12)_ - `locations.women's and children's hospital|adelaide|south australia|australia` — added _(2026-05-12)_ - `locations.royal women's|parkville|victoria|australia` — added _(2026-05-12)_ - `locations.sunshine|st albans|victoria|australia` — added _(2026-05-12)_ - `locations.calgary foothills medical center|calgary|alberta|canada` — added _(2026-05-12)_ - `locations.edmonton lois hole hospital for women|edmonton|alberta|canada` — added _(2026-05-12)_ - `locations.st-paul's hospital|vancouver|british columbia|canada` — added _(2026-05-12)_ - `locations.winnipeg university of manitoba|winnipeg|manitoba|canada` — added _(2026-05-12)_ - `locations.fredericton dr. everett chalmers regional hospital|fredericton|new brunswick|canada` — added _(2026-05-12)_ - `locations.moncton hospital|moncton|new brunswick|canada` — added _(2026-05-12)_ - `locations.st-john's women's health centre|st. john's|newfoundland and labrador|canada` — added _(2026-05-12)_ - `locations.hamilton mcmaster university|hamilton|ontario|canada` — added _(2026-05-12)_ - `locations.kingston|kingston|ontario|canada` — added _(2026-05-12)_ - `locations.london|london|ontario|canada` — added _(2026-05-12)_ - `locations.the ottawa hospital, general campus|ottawa|ontario|canada` — added _(2026-05-12)_ - `locations.the ottawa hospital, civic campus|ottawa|ontario|canada` — added _(2026-05-12)_ - `locations.sunnybrook health sciences|toronto|ontario|canada` — added _(2026-05-12)_ - `locations.quebec city (chul) centre hospitalier universitaire|montreal|quebec|canada` — added _(2026-05-12)_ - `locations.sainte-justine|montreal|quebec|canada` — added _(2026-05-12)_ - `locations.st-mary's hospital|montreal|quebec|canada` — added _(2026-05-12)_ - `locations.st-luc|montreal|quebec|canada` — added _(2026-05-12)_ - `locations.regina qu'appelle health region|regina|saskatchewan|canada` — added _(2026-05-12)_ - `locations.jubilee|kingston||jamaica` — added _(2026-05-12)_ - `locations.spanishtown|kingston||jamaica` — added _(2026-05-12)_ - `locations.hinchingbrooke|huntingdon|cambridgeshire|united kingdom` — added _(2026-05-12)_ - `locations.leighton|crewe|cheshire|united kingdom` — added _(2026-05-12)_ - `locations.darlington memorial hospital|darlington|county durham|united kingdom` — added _(2026-05-12)_ - `locations.fairfield|bury|lancashire|united kingdom` — added _(2026-05-12)_ - `locations.rochdale|rochdale|lancashire|united kingdom` — added _(2026-05-12)_ - `locations.lincolnshire|lincoln|lincolnshire|united kingdom` — added _(2026-05-12)_ - `locations.west middlesex university hospital|isleworth|middlesex|united kingdom` — added _(2026-05-12)_ - `locations.wansbeck general hospital|ashington|northumberland|united kingdom` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03269110.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03269110* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*