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
|
|
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
|
|
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. |