Contact information
Type
Scientific
Primary contact
Dr Caroline Fall
ORCID ID
Contact details
MRC Epidemiology Resource Centre
Southampton General Hospital
University of Southampton
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2380 777624
chdf@mrc.soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
074048
Study information
Scientific title
Mumbai Maternal Diet Study: randomised controlled trial of micronutrient-dense food before and during pregnancy to prevent low birthweight
Acronym
Project Saras
Study hypothesis
Supplementation of women with a food-based micronutrient-rich supplement for at least three months prior to conception, and throughout pregnancy, will reduce the incidence of low birthweight, reduce infant mortality, and improve functional outcomes in the children, including growth, neuro-cognitive function and cardiovascular disease risk factors.
Ethics approval
1. UK: Southampton and South West Hampshire Local Research Ethics Committee, 13/01/2003, ref: 377/02/t
2. Mumbai: BYL Nair and TN Medical College Ethics Committee, 17/09/2002
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy outcome and infant mortality
Intervention
Women who are not pregnant, but are planning to have further children, will be recruited and randomised to one of four groups, to receive one of two interventions: a daily food-based supplement made from vegetables, fruit, and milk, of differing micronutrient content. Supplementation will be supervised. Field staff will record menstrual dates, in order to detect pregnancy as early as possible. Women who become pregnant will have investigations during pregnancy, including blood samples and ultrasound scans.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
1. Birthweight
2. Infant mortality
Secondary outcome measures
1. Maternal micronutrient status
2. Maternal infection load and immune status
3. Foetal losses (miscarriages and stillbirths)
4. Newborn body composition
5. Newborn immune function
Overall trial start date
09/01/2006
Overall trial end date
31/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women living in slum communities in Bandra and Khar districts of Mumbai served by the Women of India Network (WIN) primary health care clinics
2. Women who wish to join
3. Married
4. Aged 15 to 35 years
5. Not pregnant at recruitment
6. Not using any PERMANENT form of contraception
7. Intending to have more children
8. Planning any future deliveries in Mumbai
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
4000
Total final enrolment
6513
Participant exclusion criteria
1. Women living outside the study area
2. Non-married women
3. Women outside the age range specified
4. Women currently pregnant (these may become eligible after delivery)
5. Women who have undergone sterilisation surgery, or whose husbands have had a vasectomy
6. Women definitely not planning further pregnancies
7. Women definitely planning further deliveries outside Mumbai
Recruitment start date
09/01/2006
Recruitment end date
30/06/2009
Locations
Countries of recruitment
India
Trial participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Centre for the Study of Social Change (India)
Sponsor details
MN Roy Human Development Campus
Plot 6
F Block
Opp Gonvt Colony 326
Bandra
Mumbai
400 051
India
+91 (0)22 30949666
rdpotdar@snehamrc.com
Sponsor type
Other
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Funder name
Parthenon Trust, ICICI Ltd (Mumbai)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The United States Agency for International Development (USAID)/The International Life Sciences Institute (ILSI) (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25332324
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27281802
2018 results in https://pubmed.ncbi.nlm.nih.gov/30419799/ (added 14/04/2020)
Publication citations
-
Results
Potdar RD, Sahariah SA, Gandhi M, Kehoe SH, Brown N, Sane H, Dayama M, Jha S, Lawande A, Coakley PJ, Marley-Zagar E, Chopra H, Shivshankaran D, Chheda-Gala P, Muley-Lotankar P, Subbulakshmi G, Wills AK, Cox VA, Taskar V, Barker DJ, Jackson AA, Margetts BM, Fall CH, Improving women's diet quality preconceptionally and during gestation: effects on birth weight and prevalence of low birth weight-a randomized controlled efficacy trial in India (Mumbai Maternal Nutrition Project)., Am. J. Clin. Nutr., 2014, 100, 5, 1257-1268, doi: 10.3945/ajcn.114.084921.
-
Results
Sahariah SA, Potdar RD, Gandhi M, Kehoe SH, Brown N, Sane H, Coakley PJ, Marley-Zagar E, Chopra H, Shivshankaran D, Cox VA, Jackson AA, Margetts BM, Fall CH, A Daily Snack Containing Leafy Green Vegetables, Fruit, and Milk Before and during Pregnancy Prevents Gestational Diabetes in a Randomized, Controlled Trial in Mumbai, India, J Nutr, 2016 , jn223461.