| CTRI Number |
CTRI/2025/01/079512 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Vitamin C to reduce complications in born too early babies. |
|
Scientific Title of Study
|
Study Of Ascorbic acid supplementation In reducing morbidities in preterm neonates A Randomized open label Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M P Sri Hira |
| Designation |
Junior Resident |
| Affiliation |
BLDE Deemed Shri B M Patil Medical College Hospital and Research Centre |
| Address |
Department of Paediatrics
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre
Bijapur
KARNATAKA
586103
India |
| Phone |
8618220569 |
| Fax |
|
| Email |
srihira20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra H Gobbur |
| Designation |
Professor |
| Affiliation |
BLDE Deemed Shri B M Patil Medical College Hospital and Research Centre |
| Address |
Department of Paediatrics
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre
Bijapur
KARNATAKA
586103
India |
| Phone |
9449575922 |
| Fax |
|
| Email |
rhgobbur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M P Sri Hira |
| Designation |
Junior Resident |
| Affiliation |
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre |
| Address |
Department of Paediatrics
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre
Bijapur
KARNATAKA
586103
India |
| Phone |
8618220569 |
| Fax |
|
| Email |
srihira20@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre Bijapur 586103 Karnataka India |
|
|
Primary Sponsor
|
| Name |
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre |
| Address |
Shri B M Patil Medical College, Hospital and Research Centre Bangaramma Sajjan Campus Solapur Road Bijapur 586103 Karnataka State India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| M P Sri Hira |
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre |
Department of Paediatrics
BLDE Deemed to be University Shri B M Patil Medical College Hospital and Research Centre
Bijapur
KARNATAKA |
8618220569
srihira20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee S B M P M C |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Without Vitamin C Supplementation. |
| Intervention |
Vitamin-C kid Syrup |
40 mg/kg Body Weight
Once daily
Administered orally or through Ryles tube upto 7 days
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
20.00 Day(s) |
| Gender |
Both |
| Details |
gestational age less than 37 weeks
birth weight less than 2.5 kg
stable babies on oral or NG tube feeds |
|
| ExclusionCriteria |
| Details |
congenital ,chromosomal anomalies.
critically sick babies
known inborn errors of metabolism. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of NICU stay |
one or two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ROP NEC and IVH RDS |
two weeks |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The wide-ranging health benefits and effects of Ascorbic are well established in adults, along with the tolerable upper intake level (2g/day). However, Vitamin C dosage for preterms with very low birth weight infants as available in the extant literature ranges anywhere between 10-55 mg/kg/day as prescribed by American and European health institutes. There exists limited knowledge on the optimal intake levels along with the role of vitamin C in preterms in reducing associated morbidities like NEC, hyperbilirubinemia, and ROP. Most of the existing literature is also confined to developed countries, where maternal smoking plays a significant role in the plasma ascorbic acid levels of preterm infants, and the findings from such studies may not fully apply to developing countries, such as India necessitating the current study. |