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.
- Conditions
- Prevention of Acute Diarrhoea, Acute Respiratory tract infections, and increase in growth in apparently healthy infants of 6-11 months of age
- Registration Number
- CTRI/2010/091/001417
- Lead Sponsor
- Indian Council Of Medical Research
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 220
The study would include apparently healthy infants of 6-11 months of age.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the incidence of diarrhoea, Acute respiratory tract infections and increase in height and weight 5 months
- Secondary Outcome Measures
Name Time Method difference in duration of episodes of diarrhea and ARI end of follow up period of 5 months
Trial Locations
- Locations (1)
Department of Community Medicine, MAulana Azad Medical College
🇮🇳Delhi, DELHI, India
Department of Community Medicine, MAulana Azad Medical College🇮🇳Delhi, DELHI, IndiaDr Akash MalikPrincipal investigator09953419276drakashmalik28@gmail.com