ISRCTN ISRCTN62811278
DOI https://doi.org/10.1186/ISRCTN62811278
Secondary identifying numbers 074048
Submission date
11/01/2006
Registration date
11/01/2006
Last edited
27/03/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Caroline Fall
Scientific

MRC Epidemiology Resource Centre
Southampton General Hospital
University of Southampton
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone +44 (0)2380 777624
Email chdf@mrc.soton.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMumbai Maternal Diet Study: randomised controlled trial of micronutrient-dense food before and during pregnancy to prevent low birthweight
Study acronymProject Saras
Study objectivesSupplementation 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(s)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
Health condition(s) or problem(s) studiedPregnancy outcome and infant mortality
InterventionWomen 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 typeSupplement
Primary outcome measure1. Birthweight
2. Infant mortality
Secondary outcome measures1. 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 study start date09/01/2006
Completion date31/03/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants4000
Total final enrolment6513
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment09/01/2006
Date of final enrolment30/06/2009

Locations

Countries of recruitment

  • England
  • India
  • United Kingdom

Study participating centre

Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Sponsor information

Centre for the Study of Social Change (India)
Other

MN Roy Human Development Campus
Plot 6, F Block
Opp Gonvt Colony 326
Bandra, Mumbai
400 051
India

Phone +91 (0)22 30949666
Email rdpotdar@snehamrc.com

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / International organizations
Location
United Kingdom
Parthenon Trust, ICICI Ltd (Mumbai)

No information available

The United States Agency for International Development (USAID)/The International Life Sciences Institute (ILSI) (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2014 Yes No
Results article results 01/07/2016 Yes No
Results article results 01/07/2019 14/04/2020 Yes No
Results article Follow up results 07/01/2022 12/01/2022 Yes No
Results article 18/02/2023 27/03/2023 Yes No

Editorial Notes

27/03/2023: Publication reference added.
12/01/2022: Publication reference added.
14/04/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2014 reference.
10/06/2016: Publication reference added.