Trials / Completed
CompletedNCT03269110
Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 664 (actual)
- Sponsor
- Ottawa Hospital Research Institute · Academic / Other
- Sex
- All
- Age
- 4 Years – 6 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Autism Spectrum Disorder
- Asthma
- Executive Dysfunction
- Emotional Problem
- Behavioural Problem
- Pre-Eclampsia
- Death
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | SRS 2, CBCL, BRIEF-P | This study does not involve an intervention. |
Timeline
- Start date
- 2017-07-01
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2017-08-31
- Last updated
- 2025-04-18
Locations
58 sites across 4 countries: Australia, Canada, Jamaica, United Kingdom
Source: ClinicalTrials.gov record NCT03269110. Inclusion in this directory is not an endorsement.