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CTRI Number  CTRI/2025/08/093478 [Registered on: 22/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The Link Between Poor Diet Diversity and Nutrient Deficiency in Children Under Five. 
Scientific Title of Study   MINIMUM DIETARY DIVERSITY AND ITS ASSOCIATION WITH MICRONUTRIENT DEFICIENCY IN UNDER FIVE CHILDREN. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishal kumar 
Designation  Post Graduate Resident 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Department of Pediatrics Maulana Azad Medical College, 2, Bahadurshah Zafar Marg, New Delhi. New Delhi DELHI 110002 India

Central
DELHI
110002
India 
Phone  9717043042  
Fax    
Email  visalchauhan173@gmai.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aashima Dabas 
Designation  Professor 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Department of Pediatrics Maulana Azad Medical College, 2, Bahadurshah Zafar Marg, New Delhi. New Delhi DELHI 110002 India

Central
DELHI
110002
India 
Phone  9968604424  
Fax    
Email  dr.aashimagupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vishal kumar 
Designation  Post Graduate Resident 
Affiliation  Maulana Azad Medical College and Lok Nayak Hospital 
Address  Department of Pediatrics Maulana Azad Medical College, 2, Bahadurshah Zafar Marg, New Delhi. New Delhi DELHI 110002 India

Central
DELHI
110002
India 
Phone  9717043042  
Fax    
Email  visalchauhan173@gmai.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College , New Delhi 
 
Primary Sponsor  
Name  Maulana Azad Medical College and Lok Nayak Hospital  
Address  Department of Pediatrics, Maulana Azad Medical College, 2,Bahadurshah Zafar Marg New Delhi New Delhi DELHI 110002 India 
Type of Sponsor  Government medical college 
 
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 Vishal Kumar  Lok Nayak Hospital, New Delhi  Department of Pediatrics, Maulana Azad Medical College, 2,Bahadurshah Zafar Marg New Delhi New Delhi DELHI 110002 India
Central
DELHI 		 9717043042

visalchauhan173@gmai.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College and Associated Hospitals(Lok Nayak, GB Pant Institute Post Graduate Medical Education (GIPMER) and Research hospital, Guru nanak Eye Centre, New Delhi-110002  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E619||Deficiency of nutrient element, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  9.00 Month(s)
Age To  60.00 Month(s)
Gender  Both 
Details  Children aged 09-60 months presenting with any acute illness 
 
ExclusionCriteria 
Details  1.Known chronic systemic or neurological disease
2.Malabsorption states
3.Prior Gastrointestinal surgery
4.Food allergies
5.Known chromosomal abnormality or congenital syndrome.
6.Feeding problems : Cleft lip / Cleft palate / Gastroesophageal Reflux Disease.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of under five children with MDD failure   1 week 
 
Secondary Outcome  
Outcome  TimePoints 
1.Association of MDDF with anemia /nutritional rickets /vitamin B deficiency.
2. Association of MDDF with Weight-for age, length/height-for age, weight for length/height
3. Association of MDDF with socio-demographic risk factors.

 		 1 week 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   07/09/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included visalchauhan173@gmail.com).

  6. For how long will this data be available start date provided 20-12-2029 and end date provided 20-12-2033?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study aims to assess the Minimum Dietary Diversity (MDD) and its association with micronutrient deficiencies in children aged 9 to 60 months presenting with acute illnesses at the Pediatric Emergency or OPD of Lok Nayak Hospital. Eligible children will be enrolled after obtaining informed consent from their caregivers.

A detailed history—including socio-demographic data, presenting complaints, past medical history, drug intake, allergy, and feeding patterns—will be recorded using a predefined proforma. Nutritional history will focus on the average dietary intake over three consecutive days (including weekdays and weekends) to estimate dietary diversity and calculate the Minimum Dietary Diversity Score based on WHO questionnaires adapted for different age groups.

Clinical examination will assess general health and identify signs of malnutrition and micronutrient deficiencies. Anthropometric measurements will be taken and interpreted using WHO growth charts for children aged 0–5 years.

A 3 mL venous blood sample will be collected to analyze hemogram, serum calcium, phosphate, alkaline phosphatase, 25-hydroxy vitamin D, vitamin B12, and folate levels. Diagnoses of anemia, rickets, and vitamin B deficiencies will be made according to National Health Mission guidelines.

This comprehensive approach will help establish the link between dietary diversity and micronutrient deficiencies among under-five children in the study population.


 
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