Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation

NCT01932788 on ClinicalTrials.gov Phase 3 Medical University of South Carolina (academic or other) Started 2013-01-31 Completed

Riskier than 8% of active trials

Model scores of the 29,894 trials active now.

Model score 7% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (741 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 2018-04-30, after 2013-01-31 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 2018-04-30. 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

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 11.7% (raises risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Phase: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 42 (lowers risk) · Sponsor's track record
Blinding: quadruple (lowers risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 9.2% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Maximum age: 45 (lowers risk) · Who can join
Collaborators: 1 (raises risk) · Design

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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 45 (typical: 71)
Sex: female (typical: all)
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 111 (typical: 32)
Sponsor's past termination rate: 11.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 42 (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: 57277 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 13320 (typical: 412.5)
Drug's FAERS reports marked serious: 70.3% (typical: 85.6%)
Drug's FAERS reports with a death: 9.2% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
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

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
Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy NCT04591847 · started 2020 · scored riskier than 6% of active trials completed
Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia NCT03101150 · started 2012 · scored riskier than 6% of active trials completed
Sunshine 2 Study for Women With Diabetes NCT01904032 · started 2013 · scored riskier than 10% 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.