| CTRI Number |
CTRI/2025/03/081663 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
secondary analysis of stored biospecimens |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of trace metals in mothers breast milk |
|
Scientific Title of Study
|
Exploring the Interplay Between Micronutrients in Human Milk and Infant Growth in the Indian Population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpa Bhaise |
| Designation |
Nutrition Consultant |
| Affiliation |
Lata Medical Research Foundation |
| Address |
Lata Medical Research Foundation
Nutrition Research Department
C/o 9/1, Kinkine Kutir, Vasant Nagar, Nagpur
Nagpur
MAHARASHTRA
440022
India |
| Phone |
09823350019 |
| Fax |
|
| Email |
shilpabhaise.lmrf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Bhaise |
| Designation |
Nutrition Consultant |
| Affiliation |
Lata Medical Research Foundation |
| Address |
Lata Medical Research Foundation
Nutrition Research Department
C/o 9/1, Kinkine Kutir, Vasant Nagar, Nagpur
Nagpur
MAHARASHTRA
440022
India |
| Phone |
09823350019 |
| Fax |
|
| Email |
shilpabhaise.lmrf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Bhaise |
| Designation |
Nutrition Consultant |
| Affiliation |
Lata Medical Research Foundation |
| Address |
Lata Medical Research Foundation
Nutrition Research Department
C/o 9/1, Kinkine Kutir, Vasant Nagar, Nagpur
Nagpur
MAHARASHTRA
440022
India |
| Phone |
09823350019 |
| Fax |
|
| Email |
shilpabhaise.lmrf@gmail.com |
|
|
Source of Monetary or Material Support
|
| Micronutrient Data Innovation Alliance
1201 Eye Street NW 10th Floor, Washington, District of Colombia 20005, USA |
|
|
Primary Sponsor
|
| Name |
MICRONUTRIENT FORUM |
| Address |
1201 Eye Street NW 10th Floor, Washington, District of Colombia 20005, USA |
| Type of Sponsor |
Other [central platform for evidence and advocacy to improve micronutrient health] |
|
|
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 Shilpa Bhaise |
Lata Medical Research Foundation |
Nutrition Research Department
Lata Medical Research Foundation C/o 9/1, Kinkine Kutir, Vasant Nagar,
Nagpur
MAHARASHTRA |
88064 95777
shilpabhaise.lmrf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lata Medical Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Human milk samples collected at 1 week, 3 months and 6 months time points, |
|
| ExclusionCriteria |
| Details |
1. Non Viable Samples
2. Samples other than human milk |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between micronutrients in human milk with infant growth |
Endline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Addresses the prevailing gap in robust data & insights into Human Milk micronutrient levels of breastmilk, particularly in the Indian context |
Endline |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
15/03/2025 |
| 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="1"
Days="0" |
|
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
|
Background: The present study examines
the relationship between micronutrient concentrations in human milk (HM) and
infant growth in Indian population. Because, there is limited data on how HM
micronutrients influence infant health and development, where most studies have
been small-scale or short-term.
Rationale and Purpose: SThe micronutrient deficiency in maternal diet raises concerns about the
potential impact on breastmilkof exclusively breastfed infants and a plausible
link between milk nutrient levels and itseffects on infant health and
developmental outcomes. Despite these insights, the precise influence ofHM
micronutrients on infant growth remains insufficiently explored. Maternal
nutrition directly affects the levels of essential micronutrients in HM,
including vitamins and minerals, which may impact infant growth. However, there
is a lack of comprehensive longitudinal studies that analyse these
micronutrients and their combined effects on infant health. We intend to
analysis of the concentrations of micronutrients such as minerals, present in
human milk. The HM samples were previously collected and stored as a part of
the Human Milk & Infant Nutrition (HMIN)longitudinal study which was a sun
study of a larger trial of Intrapartum Azithromycin to prevent sepsis in
mothers that concluded in November 2022.
Objectives:(i) To determine the composition
of mineral micronutrients concentration in human milkwith a longitudinal
sampling at 1 week, 3 months and 6 months timepoints, (ii) To study the
association of mineral micronutrients with infant growth
Methods: The study will analyse
three hundred HM samples,previously collected from the participants in the
HMIN study, for concentration of minerals such as zinc (Zn), magnesium
(Mg), calcium (Ca), selenium (Se), mercury (Hg), and lead (Pb).
Study Duration: One year (The study started February
2024 and will end February 2025)
Expected Outcomes:(i) A mineral micronutrient dataset would be
created to provide valuable insights into
the nutritional profile of human milk among the Indian sub-population. (ii)
Inform on the correlations between mineral micronutrient levels at various time
points and respective infant growth trajectories. |