CTRI Number |
CTRI/2019/07/020029 [Registered on: 04/07/2019] Trial Registered Prospectively |
Last Modified On: |
25/11/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Other |
Public Title of Study
|
Understanding the effect of feeding practices of babies on their health status in rural areas through various approaches |
Scientific Title of Study
|
Impact of feeding practices and nutrition composition on infant health status of rural population- A multi-dimensional study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vidya Rajesh |
Designation |
Dietician |
Affiliation |
Manipal Academy of Higher Education |
Address |
Room No. 4
Medicine OPD,
DR. TMA PAI ROTARY HOSPITAL,
Kabettu, Karkala.
Udupi KARNATAKA 574104 India |
Phone |
09482275837 |
Fax |
|
Email |
vidya.poojary@manipal.edu |
|
Details of Contact Person Scientific Query
|
Name |
Dr Asha Hegde |
Designation |
Professor and HOD |
Affiliation |
Manipal Academy of Higher Education |
Address |
Room no 19,
Department of Pediatrics,
DR. TMA PAI ROTARY HOSPITAL.
Kabettu, Karkala.
Udupi KARNATAKA 574104 India |
Phone |
09448824967 |
Fax |
|
Email |
asha.hegde@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Vidya Rajesh |
Designation |
Dietician |
Affiliation |
Manipal Academy of Higher Education |
Address |
Room No 4,
Medicine 0PD,
Dr. TMA Pai Rotary Hospital,
Kabettu,Karkala.
Udupi KARNATAKA 574104 India |
Phone |
09482275837 |
Fax |
|
Email |
vidya.poojary@manipal.edu |
|
Source of Monetary or Material Support
|
Vidya Rajesh,
Dr. TMA Pai Rotary Hospital,
Karkala, Udupi, Karnataka. |
|
Primary Sponsor
|
Name |
Vidya Rajesh |
Address |
Dr TMA Pai Rotary Hospital
Karkala,Udupi, Karnataka. |
Type of Sponsor |
Other [Self] |
|
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 |
Vidya Rajesh |
Dr TMA Pai Rotary Hospital |
Room No 19
Pediatrics OPD
Department of Pediatrics Udupi KARNATAKA |
9482275837
vidya.poojary@manipal.edu |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kasturba Medical College and Kasturba hospital Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy full term new borns |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
0.00 Day(s) |
Age To |
12.00 Month(s) |
Gender |
Both |
Details |
Healthy full-term babies born in TMA Pai Rotary Hospital, Karkala.
cohort- Mother and baby pair residing within 30kms of Karkala |
|
ExclusionCriteria |
Details |
Babies born before 37 weeks of gestation or having congenital abnormalities.
Mothers not willing to participate in the study. |
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
To be able to evaluate the effect of type of infant feeding and nutrient composition of the diet on the development of gut microbiome. |
4th year |
|
Secondary Outcome
|
Outcome |
TimePoints |
To analyze the effect of infant nutrition-gut microbiome association on body composition, the frequency of infectious diseases and development milestones in infants. |
4th year |
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
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)
|
08/07/2019 |
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="4" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Adequate nourishment is important for physical growth and mental development during infancy. It is also a phase of maximum brain development wherein insufficient food intake would lead to irreversible damage (Rai, 2011). Assessing the nutritional status of rural infants is pivotal, as about 67% of Indian population still live in rural areas (data world bank, 2018). In India, research prioritization in Maternal, Newborn, Child Health and Nutrition (MNCHN) themes have traditionally involved only a handful of experts mainly hailing from major cities (Narendra K. Arora, 2017). This gives the opportunity to review infant nutritional status in a rural population. Development of the gut microbiota during infancy functions as an important determinant of future health status (Yang, 2016). Dietary habits regulate what we are “feeding†our microbiota (Kashtanova, 2016), as the nutrient provided acts as a substrate for microbial metabolism. Diet composition and feeding practices during the first years of life may impact the diversity and functional capacity of the gut microbiome with potential downstream effects on infant development and disease risk (Johnson & Versalovic, 2012). Gut microbiome is now believed to affect the body mass index (BMI), as well as cognitive and neurological developments. Studying the growth trajectory and developmental milestones will provide a clear picture of the inter-relationship among nutrition, gut microbiome, BMI and development in an infant. Malnutrition is also linked with impaired immunity with consequently increased risk to infections and cytokine activation (Uday A. Paia, 2018). Studying the frequency of acute respiratory infections (ARI) and acute diarrheal diseases (ADD), which are the most common illnesses in infancy, will aid in co-relating the impact of nutrition and composition of gut microbiome on the health profile of infants. The study aims to evaluate the impact of infant nutrition in terms of feeding practices and nutrition composition on infant health with reference to multidimensional aspects including growth trajectory, development milestones, gut microbiome and disease pattern. |