Startup
Month 1-2Protocol, Ethics, Site Selection.
Study Rationale
Addressing the Vitamin D deficiency gap with Nano-emulsion technology.
The Challenge
Vitamin D deficiency remains pervasive in Indian children despite abundant sunshine, leading to rickets and impaired immunity. Conventional oil-based formulations often suffer from variable absorption.
The Solution: Kidrich-D3
Leveraging Nano-emulsion technology to reduce particle size, bypass physiological barriers, and significantly enhance cholecalciferol solubility and absorption.
The Evidence Gap
A lack of head-to-head RWE comparing Kidrich-D3 against market leaders. This study aims to validate its superior effectiveness and speed of action.
Study Objectives
Primary Objective
Comparative Efficacy
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 competing Vitamin D3 800 IU/ml brands.
Response Rate
Proportion achieving sufficiency (>30 ng/mL) at Week 8 & 12.
Speed of Action
Early absorption assessment at Week 4.
Compliance
Adherence and palatability (VAS score).
Safety Profile
Incidence of AEs (e.g., GI discomfort).
Study Design Options
Gold Standard
Option 1: Comparative Study
Goal: Prove Superiority over Competitors
- N = 300 (150 per arm)
- Multi-center, Prospective, Observational
- 12 Weeks Duration
Group A: Kidrich-D3
VS
Group B: Top Brands
Cost-Effective
Option 2: Single-Arm Study
Goal: Demonstrate Effectiveness & Safety
- N = 150 (Kidrich-D3 Only)
- Multi-center, Prospective, Observational
- 12 Weeks Duration
Single Group: Kidrich-D3
Estimated Timelines
Option 1: Comparative (~9 Months)
1
2
Execution
Month 3-6Recruitment (300 subjects).
3
Follow-up
Month 4-912-week follow-up per patient.
4
Analysis
Month 10-11DB Lock, Stats, Manuscript.
Option 2: Single-Arm (~6 Months)
1
Startup
Month 1Protocol, Fast-track Selection.
2
Execution
Month 2-3Recruitment (150 subjects).
3
Follow-up
Month 3-612-week follow-up.
4
Analysis
Month 7Report Construction.
Commercials (Budgetary Proposal)
Estimated costs subject to final site negotiation. Excludes GST.
| Line Item | Description | Option 1 (Comparative) | Option 2 (Single-Arm) |
|---|---|---|---|
| Professional Fees | |||
| Project Management | Study management, monitoring | 22,50,000 | 14,00,000 |
| Medical Writing | Protocol, IMPD, CSR, Manuscript | 3,50,000 | 3,00,000 |
| Data Mgmt & Stats | Data collection, cleaning, analysis | 4,00,000 | 2,50,000 |
| Site & Investigator Costs | |||
| Investigator Grants | Fees for Investigators | 7,50,000 | 3,75,000 |
| Ethics Committee | Independent Ethics Committee | 2,00,000 | 2,00,000 |
| Diagnostics | |||
| Lab Tests | Serum 25(OH)D (Baseline + End) | 9,00,000 | 4,50,000 |
| Operational Costs | |||
| Site Initiation/Misc | Logistics, Contingencies | 7,00,000 | 3,00,000 |
| Total Estimated Budget | ~ INR 55,50,000 | ~ INR 32,75,000 | |