| CTRI Number |
CTRI/2010/091/001417 [Registered on: 01/11/2010] |
| Last Modified On: |
21/02/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effect of Zinc sulfate in reducing the incidence of diarrhea, acute respiratory tract infections and in promoting growth in infants of 6-11 months of age. |
Scientific Title of Study
Modification(s)
|
Effect of prophylactic zinc supplementation on incidence of acute diarrhoea, respiratory tract infection and growth in infants of 6-11 months of age. |
| Trial Acronym |
EPZDAG |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Akash Malik |
| Designation |
Junior Resident (MD student) |
| Affiliation |
|
| Address |
GC-16, shivaji enclave
New Delhi
DELHI
110027
India |
| Phone |
09953419276 |
| Fax |
|
| Email |
drakashmalik28@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr DK Taneja |
| Designation |
Director Proffessor, Department Of Community Medicine |
| Affiliation |
|
| Address |
Room no. 361, 3rd floor Pathology Block, Department Of Community Medicine
Maulana Azad Medical College, Bahadur Shah Zafar Marg
New Delhi
DELHI
110002
India |
| Phone |
09968604244 |
| Fax |
|
| Email |
davendrataneja@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Akash Malik |
| Designation |
Junior Resident (MD student) |
| Affiliation |
|
| Address |
GC-16, shivaji enclave
New Delhi
DELHI
110027
India |
| Phone |
09953419276 |
| Fax |
|
| Email |
drakashmalik28@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Maulana Azad Medical College |
|
Primary Sponsor
Modification(s)
|
| Name |
Indian Council Of Medical Research |
| Address |
Ansari Nagar
New Delhi - 110029
India |
| Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| ICMR |
Indian Council Medical Research, Ansari nagar, New Delhi |
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akash Malik |
Department of Community Medicine, MAulana Azad Medical College |
2-bahadurshah zafar marg,-110002
New Delhi
DELHI |
09953419276
drakashmalik28@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of Acute Diarrhoea, Acute Respiratory tract infections, and increase in growth in apparently healthy infants of 6-11 months of age |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
syrup base |
5ml/day for 14 days |
| Intervention |
zinc sulfate |
20mg/5ml per day for 14 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
6.00 Month(s) |
| Age To |
11.00 Month(s) |
| Gender |
Both |
| Details |
The study would include apparently healthy infants of 6-11 months of age. |
|
| ExclusionCriteria |
| Details |
Recieving zinc supplement currently or in past 3 months; child who is severy malnourished, immunodeficient or on steroid therapy, severly ill requiring hospitalisation; and children of families who are not likely to stay in the study area till completion of the study |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| the incidence of diarrhoea, Acute respiratory tract infections and increase in height and weight |
5 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| difference in duration of episodes of diarrhea and ARI |
end of follow up period of 5 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/01/2011 |
| 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
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a community based double blind, randomised control trial to study the effect of prophylactic zinc supplementation in reducing the incidence of acute diarrhea, respiratoy tract infections and growth in infants of 6-11 months of age that will be conducted in Gokulpuri, a urban re-settlement colony and Urban field practice centre of Department of Community Medicne, MAMC. the primary outcomes will be decrease in the number of episodes of diarrhoea, respiratory tract infections and increase in height and weight.
Update as on 14/06/2012 The current study was a double blinded, randomised, controlled trial to study the effect of prophylactic zinc supplementation on incidence of diarrhoea, acute respiratory infections and growth among infants of 6-11 months of age. A total of 272 apparently healthy infants were randomized into two groups, one received 20 mg / day of zinc (N = 141) for 2 weeks and other received placebo (N = 131). Both the groups were followed up for 5 months. During the follow up period, data regarding the episodes of diarrhoea and ARIs were collected every 15 days and measurement of weight and length were done every month. Finally, 258 infants were included in the final analysis (N = 134 in zinc group and N = 124 in placebo group). The effect of zinc supplementation on the above mentioned outcomes at the end of the follow up period of 5 months can be concluded as follows, ·Diarrhoea:- Significant reduction was seen in § Episodes of all types of diarrhoea at the end of 5 months, § Episodes of diarrhoea for every month till 5 months. § Days with diarrhoea as well as duration of diarrhoea. § Episodes of acute diarrhoea, persistent diarrhoea and dysentery. § Episodes of all types of diarrhoea and separately for acute diarrhoea, persistent diarrhoea as well as dysentery in stunted as well as wasted infants. § Episodes of all types of diarrhoea and separately for acute diarrhoea, persistent diarrhoea as well as dysentery in both males and females. ·Acute Respiratory Infections:- Significant reduction in § Days with ARIs as well as duration of ARIs. § Episodes of ALRIs. § Episodes of ALRIs in stunted as well as wasted infants. § Episodes of ALRIs for both males and females. · Growth:- Significant increase in § Weight at end of 5 months. §Weight for every month till 1st three months. § Weight in normal infants. § Weight in both males and females. Length only in 1st month. Thus, the current study showed that short course prophylactic zinc supplementation significantly reduced the burden of diarrhoea and ALRI. Also it significantly increased the weight when compared to the placebo group. However, no effect was seen on AURI and length. These findings suggest that short course prophylaxis of zinc may be as effective as continuous supplementation especially in infants of 6-11 months of age. |