Prospective Real-World Evidence (RWE) Study Proposal: Kidrich-D3 Nano Drops

Background

Vitamin D deficiency is a pervasive public health issue in India, affecting a significant proportion of the pediatric population despite abundant sunshine. The deficiency is linked to rickets, impaired growth, and weakened immunity. Oral supplementation is the standard of care; however, absorption (bioavailability) of conventional oil-based Vitamin D3 formulations can be variable.

The Product (Kidrich-D3)

Kidrich-D3 utilizes advanced Nano-emulsion technology, designed to enhance the solubility and absorption of Cholecalciferol. By reducing particle size, the nano-formulation aims to bypass some of the physiological barriers to fat absorption, potentially leading to faster and higher recovery of serum Vitamin D levels.

Need for Study

Currently, there is a paucity of head-to-head Real-World Evidence (RWE) in the Indian context demonstrating that Kidrich-D3 provides clinically meaningful advantages over other market leaders (e.g., Arachitol Nano, Depura, Ultra D3). This study aims to generate evidence to validate the "superior effectiveness" claim.

Primary Objective

• To compare the mean absolute increase in Serum 25(OH)D levels from Baseline (Day 0) to Week 12 between subjects prescribed Kidrich-D3 Nano Drops and those prescribed other marketed Vitamin D3 800 IU/ml brands.

Secondary Objectives

• Response Rate: Proportion of subjects achieving Vitamin D sufficiency (>30 ng/mL) at Week 8 and Week 12.
• Speed of Action: Evaluate serum 25(OH)D levels at Week 4 to assess early absorption advantages.
• Compliance & Palatability: Assess treatment adherence and taste acceptance using a VAS score.
• Safety: Monitor incidence of adverse events (AEs) such as gastrointestinal discomfort.

• Study Type: Prospective, Multi-center, Comparative, Observational (RWE) Study.
• Population: Pediatric patients (6 months to 12 years) with Vitamin D deficiency/insufficiency (<20 ng/mL).
• Sample Size: Total N = 300 (150 per arm) to detect statistical difference with 80% power.
• Duration: 12 Weeks per patient.

Study Visits

• Visit 1 (Day 0): Diagnosis, prescription, baseline 25(OH)D test.
• Visit 2 (Week 4): Tele-check for compliance and AEs.
• Visit 3 (Week 12): End of study, repeat 25(OH)D test, Palatability survey.

Phase	Activity	Duration	Month
Phase I: Startup	Protocol, Ethics Committee, Site Selection (10-15 sites)	2 Months	1-2
Phase II: Execution	Patient Recruitment and Enrollment	4 Months	3-6
Phase III: Follow-up	Patient Follow-up (Last patient out)	3 Months	4-9
Phase IV: Analysis	Database Lock, Stats, Final Report (CSR)	1-2 Months	10-11
Phase V: Publication	Manuscript Preparation and Submission	Ongoing	12+

Costs are estimates and subject to final site negotiation.

Line Item	Description	Estimate (INR)
Professional Fees
Project Management	Study management, monitoring (10 sites)	22,50,000
Medical Writing	Protocol, IMPD, CSR, Manuscript	3,50,000
Data Mgmt & Stats	EDC setup, cleaning, analysis	4,00,000
Site & Investigator Costs
Investigator Grants	Fees for 10 Investigators (300 patients)	12,00,000
Ethics Committee	Fees for 10 sites	2,00,000
Diagnostics
Lab Tests	Serum 25(OH)D (Baseline + End)	9,00,000
Operational Costs
Site Initiation/Misc	Travel, Logistics, Contingencies	7,00,000
Total Estimated Budget		~ INR 60,00,000

* Note: Budget excludes GST and direct cost of the study drug.

• Superiority Claim: Statistical validation that Kidrich-D3 raises levels faster or higher than competitors.
• Marketing Collateral: "Real Indian Data" showing superior absorption/effectiveness.
• Key Outcome: Validated slide decks for Medical Representatives.