Vitamin D3 and the Stress-axis in MS
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 9% 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 (453 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
Terminated on 2016-11-07, after 2014-10-13 start.
Reason given by the sponsor: “other”
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 2016-11-07. 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: No (raises risk) · Who can join
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Primary purpose: other (lowers risk) · Design
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: interferondepressionmajoraxissclerosis
Phrases that lowered it: effectdiseasesintakevisitcriteria any -
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Blinding: quadruple (lowers risk) · Design
-
Phase: 2 (raises risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 64.4% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 7.9% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports before start: 88328 (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
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
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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- 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
- 88328 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 19160 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, immunology
- 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
- Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS) NCT01440062 · started 2011 · scored riskier than 58% of active trials terminated
- Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis NCT01024777 · started 2010 · scored riskier than 27% of active trials completed
- Vitamin D Supplementation in Multiple Sclerosis NCT01490502 · started 2012 · scored riskier than 85% of active trials completed
- Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome NCT01817166 · started 2013 · scored riskier than 27% of active trials completed
- A Multicentre Study of the Efficacy and Safety of Supplementary Treatment With Cholecalciferol in Patients With Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly NCT01198132 · started 2009 · scored riskier than 62% 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.