Research

Effects of fortified milk on morbidity in young children in north India: community based, randomised, double masked placebo controlled trial

BMJ 2007; 334 doi: 10.1136/bmj.39035.482396.55 (Published 18 January 2007)
Cite this as: BMJ 2007;334:140
  1. Sunil Sazawal, associate professor1,
  2. Usha Dhingra, data analyst1,
  3. Pratibha Dhingra, senior research scientist2,
  4. Girish Hiremath, postdoctoral fellow1,
  5. Jitendra Kumar, project manager2,
  6. Archana Sarkar, senior research scientist2,
  7. Venugopal P Menon, professor2,
  8. Robert E Black, professor1
  1. 1Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA
  2. 2Center for Micronutrient Research, Department of Biochemistry, Annamalai University, Chidambaram, India
  1. Correspondence to: S Sazawal ssazawal{at}jhsph.edu
  • Accepted 3 November 2006

Abstract

Objective To evaluate the efficacy of milk fortified with specific multiple micronutrients on morbidity in children compared with the same milk without fortification.

Design Community based, double masked, individually randomised trial.

Setting Peri-urban settlement in north India.

Participants Children (n=633) aged 1-3 randomly allocated to receive fortified milk (n=316) or control milk (n=317).

Intervention One year of fortified milk providing additional 7.8 mg zinc, 9.6 mg iron, 4.2 µg selenium, 0.27 mg copper, 156 µg vitamin A, 40.2 mg vitamin C, 7.5 mg vitamin E per day (three feeds).

Main outcome measures Days with severe illnesses, incidence and prevalence of diarrhoea, and acute lower respiratory illness.

Results Study groups were comparable at baseline; compliance in the groups was similar. Mean number of episodes of diarrhoea per child was 4.46 (SD 3.8) in the intervention (fortified milk) group and 5.36 (SD 4.1) in the control group. Mean number of episodes of acute lower respiratory illness was 0.62 (SD 1.1) and 0.83 (SD 1.4), respectively. The fortified milk reduced the odds for days with severe illnesses by 15% (95% confidence interval 5% to 24%), the incidence of diarrhoea by 18% (7% to 27%), and the incidence of acute lower respiratory illness by 26% (3% to 43%). Consistently greater beneficial effects were observed in children aged ≤24 months than in older children.

Conclusion Milk is well accepted as a means of delivery of micronutrients. Consumption of milk fortified with specific micronutrients can significantly reduce the burden of common morbidities among preschool children, especially in the first two years of life.

Trial registration NCT00255385.

Footnotes

  • We gratefully acknowledge the contributions of parents of children enrolled in the study and the study team, including health workers, supervisors, physicians, data management, and other support staff.

  • Contributors: SS was the principal investigator, designed the study, formulated the hypothesis, directed the study and the analyses, wrote the paper, and is guarantor. UD helped to design and develop data collection forms, designed the database management system, analysed data, and edited the paper. GH helped to interpret the results and write the paper. JK supervised the field procedures, implementation of the study, data collection, data entry, and quality control. PD and AS prepared the operation manual, were involved in design and translation of data collection forms and data collection, and prepared the manuscript. VPM helped in design, interpretation, and writing. REB contributed to design, interpretation, and writing.

  • Funding: Fonterra Brands, Auckland, New Zealand, funded the study and provided the milk powder used in the trial.

  • Competing interests: None declared.

  • Ethical approval: Human research and ethical review committee at the Johns Hopkins Bloomberg School of Public Health, and the Annamalai University, India.

  • Accepted 3 November 2006

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