Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 18% of the time (243 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2015-12-31, after 2012-10-01 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2015-12-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Minimum age: 20 (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: visitchronickidneydoserandomized
Phrases that lowered it: participantsrecurrentserumconfirmedlow -
Phase: 1/2 (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: prevention (lowers risk) · Design
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Drug's FAERS reports with a death: 9.3% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 70.7% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 12150 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 40 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 53914 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 12150 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, urogenital
- Drugs matched to FDA substances
- cholecalciferol
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy NCT04591847 · started 2020 · scored riskier than 6% of active trials completed
- Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants NCT00610688 · started 2008 · scored riskier than 9% of active trials completed
- Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation NCT01932788 · started 2013 · scored riskier than 8% of active trials completed
- Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women NCT03310307 · started 2016 · scored riskier than 7% of active trials completed
- Topical Delivery of Vitamin D3 as Vitamin D Supplementation NCT02735200 · started 2016 · scored riskier than 6% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.