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CTRI Number  CTRI/2012/08/002884 [Registered on: 13/08/2012] Trial Registered Retrospectively
Last Modified On: 03/04/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of zinc supplementation to full term infants on growth and morbidity 
Scientific Title of Study   Effectiveness of zinc supplementation to full term normal infants: A community based Double Blind, Randomized, controlled, clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIN-ZINC-03 dt. March 31, 2003  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr KVRadha Krishna 
Designation  Assistant Director/ Scientist D 
Affiliation  NATIONAL INSTITUTE OF NUTRITION 
Address  NATIONAL INSTITUTE OF NUTRITION Indian Council of Medical Research Jamai osmania (po) Hyderabad
Indian Council of Medical Research Jamai osmania (po) Hyderabad
Hyderabad
ANDHRA PRADESH
500007
India 
Phone  040-27197254  
Fax  040-27019074  
Email  vijrkk@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr KVRadha Krishna 
Designation  Assistant Director/ Scientist D 
Affiliation  NATIONAL INSTITUTE OF NUTRITION 
Address  NATIONAL INSTITUTE OF NUTRITION Indian Council of Medical Research Jamai osmania (po) Hyderabad
Indian Council of Medical Research Jamai osmania (po) Hyderabad
Hyderabad
ANDHRA PRADESH
500007
India 
Phone  040-27197254  
Fax  040-27019074  
Email  vijrkk@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  R Hemalatha 
Designation  Deputy Director/ scientist E 
Affiliation  NATIONAL INSTITUTE OF NUTRITION 
Address  NATIONAL INSTITUTE OF NUTRITION Indian Council of Medical Research Jamai osmania (po) Hyderabad
Indian Council of Medical Research Jamai osmania (po) Hyderabad
Hyderabad
ANDHRA PRADESH
500007
India 
Phone  040-27197297  
Fax  040-27019074  
Email  rhemalathanin@yahoo.com  
 
Source of Monetary or Material Support  
NATIONAL INSTITUTE OF NUTRITION 
 
Primary Sponsor  
Name  NATIONAL INSTITUTE OF NUTRITION 
Address  Indian Council of Medical Research Jamai osmania (po) Hyderabad – 500 007 Andhra Pradesh India  
Type of Sponsor  Research institution 
 
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 
R Hemalatha  Addagutta  Clinical Division, National Institute of Nutrition, Tarnaka, Jamai Osmania.
Hyderabad
ANDHRA PRADESH 
040-27197254
040-27019074
rhemalathanin@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal full term infants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5ml syrup containing 0.5mg of riboflavin  Supplemented for a total period of 14 months, from 4 months to 18 months age 
Intervention  0.5ml syrup containing 0.5mg of zinc and 0.5mg riboflavin  Supplemented for a total period of 14 months, from 4 months to 18 months age 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  3.00 Month(s)
Gender  Both 
Details  Selection criteria included term healthy infant without any obvious congenital anomalies and planning to stay in the study area till the child is of 2 years 
 
ExclusionCriteria 
Details  Preterm deliveries and infants with congenital abnormalities or birth trauma were excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Stunting  data on length was collected once in 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Morbidity  data on morbidity was collected once in 15 days 
 
Target Sample Size   Total Sample Size="427"
Sample Size from India="427" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2003 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The objective of the present study was to test if zinc supplementation initiated early, prevents stunting and promotes optimum body composition in full term infants. Neonates (2-4 months) were enrolled at home. Birth weights were recorded from the delivery records and weights were recorded at enrolment again. Anthropometric data collection like weight, length, head circumference, chest circumference, mid upper arm circumference and skin fold thicknesses at triceps, biceps, subscapular area were collected every three months. Maternal weight and height were recorded 1 month after delivery and every three months. Supplementation of zinc was started from the age of 5 months and continued till the child attained 18 months of age. There were 162 and 154 children in zinc and placebo groups respectively. The total duration of supplementation was for a period of 14 months. The control group of children received only riboflavin 0.5mg per day, whereas the intervention groups received 5 mg of zinc plus riboflavin 0.5mg per day. Blood samples were collected from cubital vein in a sub sample of 70 children at the end of the study, for estimation of Hemoglobin, Zinc, Copper and Vitamin A. Dietary intakes were calculated by 24hours recall method for 78 children. Thirty seven percent of our study mothers were chronically energy deficient. Mean calorie consumption in these infants was 590 cal per day (95% CI 526.3, 653.8) and mean zinc intakes from diets were 0.98 mg/day. Multiple linear regression models demonstrated maternal weight as strong predictor of infants’ weight and length at 18 months age. As expected, diarrhea duration impacted infant’s linear growth and weight gain adversely. Zinc supplementation had no effect on the linear growth, but increased body fat (measure by skin folds) significantly.

 

 
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