| CTRI Number |
CTRI/2024/07/069980 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Serum leptin and lipid profile before and after Omega-3 supplementation fatty acid in neonates with IUGR |
|
Scientific Title of Study
|
Serum leptin and lipid profile before and after Omega-3 supplementation fatty acid in neonates with IUGR: A randomized control trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geeta Gathwala |
| Designation |
Senior Professor , HOD, Deartment of Paediatrics, PGIMS ,Rohtak |
| Affiliation |
PGIMS,Rohtak, 124001 |
| Address |
Department of Paediatrics, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences,Rohtak ,Haryana, India,124001
Rohtak
HARYANA
124001
India |
| Phone |
9896489650 |
| Fax |
|
| Email |
geetagathwala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Gathwala |
| Designation |
Senior Professor , HOD, Deartment of Paediatrics, PGIMS ,Rohtak |
| Affiliation |
PGIMS,Rohtak, 124001 |
| Address |
Department of Paediatrics, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences,Rohtak ,Haryana, India,124001
Rohtak
HARYANA
124001
India |
| Phone |
9896489650 |
| Fax |
|
| Email |
geetagathwala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti |
| Designation |
Post Graduate |
| Affiliation |
PGIMS Rohtak,124001 |
| Address |
Department of Paediatrics,Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences,Rohtak ,Haryana, India,124001
Rohtak
HARYANA
124001
India |
| Phone |
8222088122 |
| Fax |
|
| Email |
jyotikadian38322@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Bhagwat Dayal Sharma post graduate institute of medical sciences (PGIMS Rohtak) ,Haryana ,124001 |
|
|
Primary Sponsor
|
| Name |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences,Rohtak |
| Address |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences,Rohtak ,Haryana, India,124001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Jyoti |
Department of Paediatrics ward 14, ward 16, NICU |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences,Rohtak ,Haryana, India,124001
Rohtak
HARYANA |
8222088122
jyotikadian38322@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P051||Newborn small for gestational age, (2) ICD-10 Condition: P059||Newborn affected by slow intrauterine growth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention |
No omega-3 fatty acid supplementation will be done
Remains on feeds |
| Intervention |
Omega -3fatty acid supplementation |
40 mg/kg/day in 10ml of expressed breast milk or formula milk daily in full term neonates with IUGR |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Full Term Neonate between thirty seven weeks to fourty one plus six weeks
SGA
Ponderal index less than two
On full feeds
|
|
| ExclusionCriteria |
| Details |
Preterm neonates
Neonates who died before feeding is established
neonates with congenital infection, with multiple congenital anomalies/malformation
Neonates with Cholestasis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effects of Omega-3 fatty acid supplementation on serum leptin levels of IUGR neonates |
At enrollment and at 4 week of supplementation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effects of omega 3 fatty acid supplementation on lipid profile and on anthropomertic measurements |
lipid profile: at enrollment and after 4 weeks
anthropometry: daily,weekly according to criteria |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Metabolic programming seems to be potentially reversible during a restricted postnatal critical period.Supplementation with omega - 3 fatty acid during this critical period can reverse the metabolic programming and improves the outcomes of IUGR neonates by its effect on serum leptin levels and lipid profile. This present study aims to assess the effect of omega -3 supplementation on serum leptin and lipid profile of neonates with IUGR. Intervention : omega 3 supplementation 40mg/kg/day mixed in 10 ml of expresssed breast milk or formula milk Control : no intervention Serum leptin and lipid profile assesses after 4weeks |