CURRENT PROJECTS:

  • Phase III, Multi-centric, Randomized, Double-blind, Placebo-controlled, Superiority trial to evaluate efficacy of Probiotic supplementation for prevention of Neonatal sepsis in 0-2 months old Low Birth Weight (LBW) Infants in India – ICMR/MRC

ICMR, New Delhi in collaboration with the six study sites/hospitals in India is conducting a randomized, placebo-controlled, double blind trial to evaluate the efficacy of a probiotic blend (Vivomixx Drop) in reducing the incidence of neonatal sepsis in low birth weight (LBW) infants in the 0-2-month period. A total of 6100 LBW neonates will be enrolled, 3050 each in intervention and control arm. As one of the 6 participating sites, we will be conducting a study in Meerut, UP, India in collaboration with Subharti Medical College. In this study LBW babies in the identified hospitals, meeting the eligibility criteria will be enrolled and randomized to receive either probiotic Vivomixx or a similar looking substance (placebo), once daily for 30 days. Follow up visits will be done daily at home during the first week of life, twice a week during second to fourth week of life, and weekly during the second month. During these visits, field worker will screen the infants for morbidity and refer the sick infants to the study hospital for evaluation by the physician. At the facility/hospital, examination for clinical signs, blood samples from sick infants suspected sepsis for diagnosis of neonatal sepsis will be done.

Project Location: Meerut, Uttar Pradesh, IN

Project Started: Dec 2020

Funded By: Indian Council for Medical Research / Medical Research Council (UK)

UPCOMING PROJECTS:

  • The NutriMAM Trial – Options for the nutritional management of moderate wasting in children in the context of acute infection

The NUTRI-MAM trial will aim to evaluate the efficacy of locally available foods (LAF) or microbiota directed supplementary food (MDSF) compared to RUSF, when given to moderately wasted children presenting to health facilities with an acute illness, on initial anthropometric recovery (within 12 weeks of enrolment) and sustained recovery (at 24 weeks after enrolment).

Project Location: Meerut, Uttar Pradesh, IN
Project Duration: 3 Years
Funded By: World Health Organization (WHO)

PREVIOUS PROJECTS:

  • Antibiotics for Children with Severe Diarrhoea (ABCD) Trial

Antibiotics for Children with Diarrhoea (ABCD) trial was meant to determine the efficacy of two antibiotics (azithromycin and ciprofloxacin), compared to placebo, in reducing risk of death and linear growth faltering in the three months and 6 months following an episode of diarrhoea among children (2-23 months of age) at high-risk of diarrhoea-associated mortality. In this double-blind, placebo controlled, randomized trial, 11,500 children aged 2 to 23 months presenting to hospitals in 7 Asian and African countries with acute diarrhoea and either malnutrition and or dehydration had been enrolled and randomized to receive a three-day course of azithromycin or placebo. Children were re-assessed at day-90 and then at day -180 to determine the vital status of the child and to obtain anthropometric measurements. A sub-set of children was also enrolled in the AMR sub-study and followed at day 90 and day 180 for additional stool and nasal swab collection.

Project Location: Meerut, Uttar Pradesh, IN
Project Duration: June 2016 – July 2020
Funded By: World Health Organization (WHO)

  • Establishing the optimal dose of therapeutic zinc supplementation for the treatment of acute diarrhea in under five children – a dose response trial in a South Asian and a Sub-Saharan African setting. ZTDT STUDY

The Zinc Trial Dosing Therapy (ZTDT) study was a double-blind randomized controlled trial of three doses of zinc (20mg/day, 10mg/day and 5mg/day) that was undertaken in India and Tanzania with the overall aim to identify the optimal dose of zinc in children with acute diarrhoea under the age 5 years with diarrhoea, evaluating safety of the low dose as compared to standard dose in risk of vomiting within 30 minutes. Other objectives were to evaluate if lower doses of zinc have any impact on post- acute illness morbidity, acceptability of the low dose zinc supplement and whether there is any association between different doses of zinc on plasma zinc levels at days 3,7,15, 21 and 30.

Project Location: New Delhi/Meerut, Uttar Pradesh, IN
Duration: Started: June 2016 to Dec 2019
Funded By: World Health Organization (WHO)

  • Healthy Birth, Growth and Development Knowledge Integration (HBGDki) Initiative

Access to Clinical Trial Data of the study entitled ‘Randomized double blind, controlled trial with a 2-by-2 factorial design to assess the effects of zinc or vitamin and mineral (calcium, phosphorous, folate, and iron) supplementations on development, growth, morbidity, and mortality in 1- to 9-month old SGA infants’ for the Healthy Birth, Growth and Development Knowledge Integration (HBDGk1) Initiative. The limited dataset under Agreement Letter for Data Set Alignment (ALDSA) was shared which included dataset, code book, Data Definition file, study related documents (protocol, data collection forms, CRF and published papers)

Project Location: New Delhi, IN
Duration: Mar 2017 – Mar 2018
Funded By: BIRAC (Biotechnology Industry Research Assistance Council)

  • Prospective observational study of Rotavirus Infection in infants in Sangam Vihar, New Delhi, India to prepare for a proposed Rotavirus Vaccine efficacy trial.

Project Brief: In a prospective, observational study 200 infants in two cohorts in two age intervals (6-8 weeks or 8-12 months) were enrolled and followed weekly for 6 months to evaluate the occurrence of diarrhea. This was an observational study intended to mimic all operational aspects required to successfully implement a large rotavirus Phase III vaccine efficacy trial at multiple sites in India.

Project Location: New Delhi, IN
Duration: 2011 To 2012
Funded By: PATH (Program for Appropriate Technology in Health), USA & Serum Institute of India Limited, India

  • Efficacy of High Zinc-Biofortified Wheat Consumption in Improvement of Micronutrient Status, and Prevention of Morbidity among Preschool Children (aged 4-6 years) and Women of Child Bearing Age- A Double Masked, Randomized, Controlled Trial.

This study aimed to evaluate the efficacy of Zinc bio fortified wheat flour on zinc status and its impact on morbidity; physical growth; and compliance to wheat flour among children aged 4-6 years and non-pregnant non lactating woman of child bearing age (WCBA) in Delhi, India. In a community based, double-masked randomized controlled trial, 6005 participants (WCBA and child pair) were enrolled in Sangam Vihar (a resettlement colony in outskirts of South Delhi) and Harsh Vihar (semi-urban locality in North East District of Delhi) and randomly allocated to receive either high Zinc bio fortified wheat flour (HZn, 30 ppm Zinc daily) or low Zinc bio fortified wheat flour (LZn, 20 ppm zinc daily) for 6 months (WCBA@360 g/day and children @120g/day).Weekly household surveillance was conducted to gather information on compliance and morbidity. During the follow up, dietary data was collected on a sub-sample using an interactive 24-hour dietary recall method and FFQ. The clinical examination, anthropometric measurements and blood sampling assessments were repeated at end-study (after 6 months of follow-up) to estimate changes in zinc/iron status indicators, growth parameters and prevention of morbidity.

Project Location: New Delhi, IN
Duration: 2013 To 2016
Funded By: HARVEST PLUS [Centro Internacional de Agricultura Tropical (CIAT) and International Food Policy Research Institute (IFPRI) (Via Johns Hopkins University)]

OTHER RESEARCH PROJECTS IN INDIA

  1. Effect of mode of delivery of Iron and/or iron and zinc supplement on Iron status markers and Potential markers of Iron Toxicity in children aged 24-36 months in India.

Project Duration: 2009 To 2010

Funded By: ICMR

2. Effect of Zinc Supplementation on Observed Activity and appetite of preschool Children

Duration: 09/1993 To 09/1994

Funded By: World Health Organization (WHO) and Thrasher Research Fund

3. Effect of zinc supplementation on morbidity, mortality, growth and child development in LBW-SGA children: a randomized controlled trial

Project Duration: 04/1996 To 11/1998

Funded By: National Institute of Child Health and Human Development (R01 HD374430), the Gerber Foundation, the Thrasher Foundation, Child Health at Johns Hopkins University, and the Lanata-Piazzon Partnership.

4. Effect of zinc supplementation on growth and child development in LBW-SGA children: Afollowup SGA trial – Our studies on effect of zinc supplementation on SGA children were the first to demonstrate the effect of zinc supplementation on mortality.

Project Duration: 1999 To 2001

Funded By: National Institute of Child Health and Human Development (R01 HD374430), The Gerber Foundation, The Thrasher Foundation, Child Health at Johns Hopkins University, and the Lanata-Piazzon Partnership.

5. Acceptability and Compliance of food-based approach to improve development and reduce anaemia, morbidity and growth faltering in infants by preventing micronutrient deficiencies.

Project Duration: 01/1999 To 12/1999

Funded By: Thrasher Foundation

6. Evaluating efficacy of Milk Fortified with Bifidus DR10-Oligosaccharides, Zinc and Iron in reducing morbidity due to diarrhoea, pneumonia and improving growth and development in children 12-36 months

Project Duration: 04/2002 To 04/2004

Funded By: New Zealand Milk (now Fonterra Brands Ltd)

7. Impact of one year supplementation of Fortified milk formula on long term development in children – We are the first to demonstrate the sustained effect of milk fortification on the executive functioning of children. The findings of these projects were published in peer reviewed journals and presented in various international conferences.

Project Duration: 03/2006 To 03/2009

Funded By: New Zealand Milk (now Fonterra Brands Ltd)