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CTRI Number  CTRI/2025/03/082609 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Omega 3 Fatty Acid foood supplementation]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Heat affects on breastfeeding and baby growth  
Scientific Title of Study   Effects of heat stress on maternal lactation performance & infant growth  
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 Santu Ghosh 
Designation  Associate Professor 
Affiliation  St John’s Medical College, Bangalore 
Address  Dept. of Biostatistics St John’s Medical College, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9941005569  
Fax    
Email  santu.g@StJohns.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Santu Ghosh 
Designation  Associate Professor 
Affiliation  St John’s Medical College, Bangalore 
Address  Dept. of Biostatistics St John’s Medical College, Bangalore


KARNATAKA
560034
India 
Phone  9941005569  
Fax    
Email  santu.g@StJohns.in  
 
Details of Contact Person
Public Query  
Name  Dr Santu Ghosh 
Designation  Associate Professor 
Affiliation  St John’s Medical College, Bangalore 
Address  Dept. of Biostatistics St John’s Medical College, Bangalore


KARNATAKA
560034
India 
Phone  9941005569  
Fax    
Email  santu.g@StJohns.in  
 
Source of Monetary or Material Support  
Bill & Melinda Gates Foundation  
 
Primary Sponsor  
Name  Bill Melinda Gates Foundation 
Address  "500 Fifth Avenue North, Seattle, Washington 98109, USA"  
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Poonam P Shingade  Employees’ State Insurance Corporation (ESIC) Medical College  Dept. of community Medicine, ESIC medical college, Gulbarga,
Gulbarga
KARNATAKA 		 8454847996

Dr.poonam.ps@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, St John’s Medical College and Hospital  Approved 
NOC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  • Rural lactating women aged 20-35 years and their children within 0-4 months of age. • No major morbidities • Normal healthy growing child with normal delivery, no major morbidities  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Algal docosahexaenoic acid, DHA   Algal docosahexaenoic acid, DHA (1 g/day, heavy metal free) packaged in 500 mg gelatin capsules. The OFA oil in a dose of 1 g/day, will be formulated as soft gelatin capsules in blister packs, each of which will contain 15 capsules, each containing 500 mg DHA/EPA. Two capsules will be taken per day, 1 in the morning and 1 in the evening for 90 days.  
Comparator Agent  Placebo   gelatin capsules formulated with saline water  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Rural lactating women aged 20-35 years and their children within 0-4 months of age.
No major morbidities
Normal healthy growing child with normal delivery, no major morbidities

 
 
ExclusionCriteria 
Details  1.Major chronic illness for mother or baby
2.Intention to leave the site
3.On any supplementation/medication
4. Moderate/severe anemia
5.Likely to change employment status"
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Plasma oxidative stress markers in lactating mothers of 3-month-old babies.
Plasma oxidative stress markers arylesterase activity of paraoxanase 1 (PON-1) will be assayed.Myeloperoxidase (MPO) will be measured as the rate of oxidation of o-dianisidine .Lipid peroxidase (LPO)
will be measured as mmol thiobarbituric acid-reactive species formed on reaction of plasma.Total antioxidant (ToAx) will be measured using the TEAC method  		 Baseline and after 90 days of intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
"• Hemoglobin (Hb) concentration & iron status of lactating mothers.
• Anthropometric growth of the children."
 		 Baseline & after 90 days of intervention
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/12/2025 
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="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This is a feasibility component of an observational study with primary objective of assessing impact of climate change on lactating performance of exclusive breastfeeding mother and infant’s anthropometric growth. As causal pathways of extreme summer impacting human health are assumed to be inflammatory and oxidative stress, this feasibility study objective is to see if Omega-3 fatty acid (OFA) supplementation can improve antioxidant level of lactating mothers to cope with extreme heat stress during summer. 50 eligible lactating mothers from observational component who will be recruited in winter, 2025 -2026 in Kalaburagi, Karnataka will be randomized into two groups. One will receive daily supplementation of 1g OFA (from algal DHA capsules) packaged in 500 mg gelatin capsules for three months, and the control group receiving a placebo (gelatin capsules with saline water) during summer 2026. It will evaluate the potential of OFA to reduce oxidative stress by improving maternal antioxidant status. 
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