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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03269110




Registration number
NCT03269110
Ethics application status
Date submitted
10/08/2017
Date registered
31/08/2017
Date last updated
21/03/2024

Titles & IDs
Public title
Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
Scientific title
Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
Secondary ID [1] 0 0
CTO 816
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 0 0
Asthma 0 0
Executive Dysfunction 0 0
Emotional Problem 0 0
Behavioural Problem 0 0
Pre-Eclampsia 0 0
Death 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 0 0 0 0
Hypertension
Mental Health 0 0 0 0
Autistic spectrum disorders
Mental Health 0 0 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - SRS 2, CBCL, BRIEF-P

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.


Diagnosis / Prognosis: SRS 2, CBCL, BRIEF-P
This study does not involve an intervention.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Neurocognitive disability
Timepoint [1] 0 0
From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.
Secondary outcome [1] 0 0
Severe Morbidity
Timepoint [1] 0 0
From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.

Eligibility
Key inclusion criteria
1. Capability of participant to comprehend and comply with study requirements

2. Mother participated in FACT
Minimum age
4 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
2578
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Nepean - Penrith
Recruitment hospital [2] 0 0
Townsville - Douglas
Recruitment hospital [3] 0 0
Ipswich - Ipswich
Recruitment hospital [4] 0 0
Women's and Children's Hospital - Adelaide
Recruitment hospital [5] 0 0
Royal Women's - Parkville
Recruitment hospital [6] 0 0
Sunshine - St Albans
Recruitment postcode(s) [1] 0 0
2750 - Penrith
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
4305 - Ipswich
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Newfoundland and Labrador
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Canada
State/province [8] 0 0
Saskatchewan
Country [9] 0 0
Jamaica
State/province [9] 0 0
Kingston 7
Country [10] 0 0
Jamaica
State/province [10] 0 0
Kingston
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Cambridgeshire
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Cheshire
Country [13] 0 0
United Kingdom
State/province [13] 0 0
County Durham
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Lancashire
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Lincolnshire
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Middlesex
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Northumberland
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Tooting
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Tyne And Wear
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Blackburn
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Burnley
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Carlisle
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Crumpsall
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Durham
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Middlesbrough
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Newcastle upon Tyne
Country [28] 0 0
United Kingdom
State/province [28] 0 0
North Shields
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Norwich
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Nottingham
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Oldham
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Stockton
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Sunderland
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Uxbridge
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Warrington
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Whitehaven
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Whitley Bay
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Other
Name
Ottawa Hospital Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03269110
Trial related presentations / publications
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Public notes

Contacts
Principal investigator
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Mark Walker, MD
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The Ottawa Hospital
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03269110