Condition category
Pregnancy and Childbirth
Date applied
11/01/2006
Date assigned
11/01/2006
Last edited
10/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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)

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25332324
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27281802

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

10/06/2016: Publication reference added.