N/A
N=51
FACT Biomarker Subgroup Analysis
Pre-Eclampsia
Bottom Line
View on ClinicalTrials.gov: NCT03981029 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Folate Status — 2701; 2686; 105; 67.1 nmol/L
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 4.0mg Folic Acid received through participation in FACT (NCT01355159) (Other); Placebo received through participation in FACT (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Folate Status |
2701; 2686; 105; 67.1; 148.4; 122.8 | — |
| SECONDARY Homocysteine Status |
6; 6.4 | — |
| SECONDARY Status of Modifiers of Folate metabolism_vitamin B-12 |
217.5; 208.5 | — |
| SECONDARY Angiogenic Potential |
421.4; 331.2; 862.9; 812; 961.5; 1061.0 | — |
| SECONDARY Status of Modifiers of Folate metabolism_MTHFR Genotype (C677T) |
7; 12; 9; 15; 3; 4 | — |
| SECONDARY Status of Modifiers of Folate metabolism_ Vitamin B6 (Pyridoxal 5-phosphate) |
44.3; 40.0 | — |
Summary
The FACT Biomarker Subgroup Analysis is a pilot study of mothers who participated in the Folic Acid Clinical Trial (FACT, NCT01355159). This subgroup analysis aims to determine the effect of high-dose folic acid supplementation in pregnancy on maternal folate status and subsequent impact on risk for pre-eclampsia.
Eligibility Criteria
Individuals participating in FACT (NCT01355159) will be eligible to participate. FACT eligibility criteria are as follows:
INCLUSION criteria
- Capability of subject to comprehend and comply with study requirements
- ≥ 18 years of age at time of consent
- Subject is taking ≤1.1 mg of folic acid daily at the time of randomization
- Live fetus (documented positive fetal heart prior to randomization)
- Gestational age between 8+0 and 16+6 weeks of pregnancy (Gestational age (GA) of subjects will be calculated based on the first day of the last menstrual period (LMP) or ultrasound performed before 12+6. If early ultrasound and LMP dates differ by ≤ 7 days, base GA estimate on LMP date; if > 7 days, use early 35 kg/m2 within 3 months prior to this pregnancy and up to randomization of this pregnancy (documented evidence of height and weight to calculate BMI is required)
EXCLUSION Criteria
- Known history or presence of any clinically significant disease or condition which would be a contraindication to folic acid supplementation of up to 5 mg daily for the duration of pregnancy
- Known major fetal anomaly or fetal demise
- History of medical complications, including: renal disease with altered renal function, epilepsy, cancer, or use of folic acid antagonists such as valproic acid
- Individual who is currently enrolled or has participated in another clinical trial or who received an investigational drug within 3 months of the date of randomization (unless approved by the Trial Coordinating Centre)
- Known presence of: Alcohol abuse (≥ 2 drinks per day) or alcohol dependence, Illicit drug/substance use and/or dependence, Known hypersensitivity to folic acid, Multiple Pregnancy (triplets or more), Participation in this study in a previous pregnancy
Data sourced from ClinicalTrials.gov (NCT03981029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.