Comparison · NCT01355159-44b3b660
Folic Acid 4 mg vs Placebo: Retinopathy of Prematurity
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Folic Acid 4 mg vs Placebo: Retinopathy of Prematurity. Trial comparisons, record NCT01355159-44b3b660. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01355159-44b3b660
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0156 | 0.0103 | 0.0238 | wilson | |
| Risk in group 2 | 0.00965 | 0.00565 | 0.0164 | wilson | |
| Risk difference, group 1 minus group 2 | 0.006 | -0.00267 | 0.0151 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.62 | 0.815 | 3.22 | log | |
| Odds ratio, group 1 over group 2 | 1.63 | 0.813 | 3.27 | log | |
| Number needed to treat, for one more participant with the outcome on Folic Acid 4 mg than on Placebo | 167 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Folic Acid 4 mg | Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid~Folic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid | 21 | 1,342 | OG000 |
| Group 2 | Placebo | Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo~Placebo: Placebo x 4 tablets will be taken daily by oral administration. | 13 | 1,347 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Retinopathy of Prematurity
- Description
Retinopathy of prematurity a retinopathy typically occurring in premature infants treated with high concentrations of oxygen, characterized by vascular dilatation, proliferation, tortuosity, edema, retinal detachment, and fibrous tissue behind the lens confirmed by retinal examination according to an International Committee for the Classification of Retinopathy of Prematurity.
- Time frame
- Infants born to the participant will be followed for the duration of hospital stay, or up to 6 weeks
- Population
A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. Some participants had missing data for this outcome and therefore were excluded from this analysis.
Source ClinicalTrials.gov
Trial
- Title
- High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention
- NCT number
- NCT01355159
- Phases
- PHASE3
- Conditions
- Pregnancy Complications, Preeclampsia
- Interventions
- Folic Acid 4 mg, Placebo
- Lead sponsor
- Ottawa Hospital Research Institute
- Results first posted
- 2020-07-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01355159?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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