Cholecalciferol

Evidence Level: L5

Predicted Indications: 4

Cholecalciferol

Pharmacist Assessment Report

Cholecalciferol: From Vitamin D Deficiency and Bone Disorders to Acromesomelic dysplasia, Campailla Martinelli type

One-Sentence Summary

Cholecalciferol (vitamin D3) is a nutritional vitamin D form used for vitamin D deficiency and bone-mineral disorders such as rickets, osteomalacia and osteoporosis. The TxGNN model predicts it may be effective for acromesomelic dysplasia, Campailla-Martinelli type, an ultra-rare genetic skeletal disorder. This prediction currently has no supporting clinical trials and no publications, so it is a model output only.

Quick Overview

Item	Content
Original Indication	Vitamin D deficiency and bone-mineral disorders (osteoporosis, rickets, osteomalacia, hypoparathyroidism). These are relations recorded in the knowledge graph. The local licence records contain no approved-indication text.
Predicted New Indication	Acromesomelic dysplasia, Campailla-Martinelli type
TxGNN Prediction Score	0.9978
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data
Number of Listed Products	at least 20
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. Based on known information, cholecalciferol is a pro-hormone that is converted in the liver and kidney to active vitamin D metabolites. These metabolites support calcium and phosphate absorption and bone mineralization. Its use in vitamin D deficiency and bone-mineral disorders is the basis for the model’s link to a skeletal disease.

The link to this new indication is weak. Acromesomelic dysplasia, Campailla Martinelli type is an ultra-rare skeletal dysplasia of genetic origin. Vitamin D’s general role in bone mineralization is only a loose, nonspecific connection. It does not address the underlying genetic defect, and no specific mechanistic pathway has been established. The very high score (0.9978) comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological or clinical confirmation.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

India Market Information

All 20 listed licences are valid single-ingredient products. The table shows five of them, and the full list may be partial. Approved-indication text is not stated in the licence records.

Authorization Number	Product Name	Dosage Form
Registration No. 38874	Cholvac-D3 Softgel Capsule	Strip of 4 soft gelatin capsules
Registration No. 217773	Tonecal-D3 Softgel Capsule	Strip of 4 soft gelatin capsules
Registration No. 115844	Kalzin 60K Tablet	Strip of 4 tablets
Registration No. 94298	Gemsoline-D3 Nano Shot	Bottle of 5 ml oral solution
Registration No. 242252	Werol 600000IU Injection	Vial of 1 ml injection

Available forms include oral capsules, tablets, chewable tablets, oral solutions and injections.

Safety Considerations

Drug Interactions: 56 interactions are recorded. The major ones are with other vitamin D-active compounds: calcifediol, calcitriol, dihydrotachysterol and doxercalciferol. Moderate interactions include thiazide diuretics (for example chlorothiazide, chlorthalidone), barbiturates (amobarbital, butabarbital, butalbital), carbamazepine, digoxin and digitoxin, and bile acid sequestrants (cholestyramine, colestipol, colesevelam).
Conditions flagged in the knowledge graph (relations recorded in the knowledge graph, not label text): hypercalcemia, nephrocalcinosis, hyperparathyroidism, sarcoidosis, kidney disease, liver disease, primary hyperoxaluria, and several others. Hypercalcemia and nephrocalcinosis risk is the main practical concern with high-dose use.

Please refer to the package insert for label warnings and contraindications.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction rests on model output alone, with no trials or publications for this disease. Cholecalciferol’s nonspecific bone-mineral role does not address the genetic cause of this skeletal dysplasia.

To proceed, the following is needed:

Any disease-specific evidence, such as case series, preclinical work or mechanistic studies, linking vitamin D pathways to this dysplasia
Mechanism of action data for cholecalciferol
Package insert warnings and contraindications from Indian labelling
A review of other predicted indications for the drug. For example, renal osteodystrophy has two related trials and several publications, though its evidence is indirect and overlaps with existing uses.
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.