A Phase I/II Dose‐Escalation Trial of Vitamin D3 with Calcium Supplementation in Patients with Multiple Sclerosis
Bibliographic record
Abstract
There is evidence to suggest that vitamin D nutritional status may influence the development and progression of multiple sclerosis (MS). To characterize the safety profile of high‐dose oral vitamin D3 in MS, we conducted a phase I/II dose‐escalation trial of vitamin D3 with calcium supplementation in patients with MS. In 52‐week trial patients with MS were matched (age, gender, disease duration, Expanded Disability Status Scale, disease modifying therapy, and MS subtype), stratified, and randomized to treatment or control. The treatment group received escalating doses of vitamin D3 (4,000â 40,000 IU/d) and calcium (1200mg/d). The primary endpoint was change in serum calcium concentrations in the treatment group. Baseline and end‐of‐trial measures of disease progression will be compared. Immune system biomarkers will be compared between baseline and end‐of‐study within the treatment group and between treatment and control subjects. Interim analysis: 9/25 treatment patients remain in‐study while 15/25 have finished. Serum and urine calcium levels have remained within normal ranges (2.2â 2.6mmol/L) for all participants with no incidence of hypercalcemia or hypercalciura. There was no significant difference between control and treatment groups. Mean serum 25(OH)D concentrations have increased significantly from 73.5 to 402.1 nmol/L (p<0.001) at the highest dose (n=14). Further results to follow.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.005 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".