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

Oleh:

Sazawal, Sunil ; Dhingra, Usha ; Hiremath, Girish ; Kumar, Jitendra ; Dhingra, Pratibha ; Sarkar, Archana ; Menon, Venugopal P. ; Black, Robert E.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: British Medical Journal (keterangan: ada di Proquest) vol. 334 no. 7585 (Jan. 2007), page 140.

Ketersediaan

Perpustakaan FK Nomor Panggil: B16.K.2007.04 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

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 IJg selenium, 0.27 mg copper, 156IJgvitamin A, 40.2 mgvitamin C, 7.5 mgvitam.in E per day (three feeds). Main outcome measures Oays 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 (SO 3.8) in the intervention (fortified milk) group and 5.36 (SO 4.1) in the control group. Mean number of episodes of acute lower respiratory illness was 0.62 (SO 1.1) and 0.83 (SO 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 regisfortified milk we conducted a community based, double masked, randomised controlled trial comparing forti¬fied milk with the same milk without fortification for prevention of common childhood morbidities. METHODS Participants-The trial was carried out in a peri-urban population in New Delhi, India, from April 2002 to April 2004. Details of the population have been previ¬ously published.67 From a regularly updated demo¬graphic database we invited all permanently resident families with children aged 1-3 years to participate in the study. Irrespective of group allocation all children who had severe anaemia at baseline were given a thera¬peutic dose of iron for three months in addition to their milk supplement. Baseline assessment, blood samples, and laboratory proce¬durerA detailed baseline assessment included examina¬tion and collection of socioeconomic and demographic information. Two independent observers measured weight to the nearest 10 g with an electronic scale and length or height to the nearest 0.1 cm with length boards. Researchers collected a venous blood sample at baseline and at the end of the study. See bmj.com for laboratory analysis. Randomisation and masking- This study was imple¬mented concurrently with another two-armed clini¬cal trial to evaluate the efficacy of a different milk preparation fortified with probiotic (compared with preparation without fortification) in a non-factorial design with joint randomisation. Each treatment group (across the two trials) was identified by a letter code A, B, C, or D. We generated two separate randomisation lists-one for children with baseline Hb > 70 g/l and another for children with baseline Hh <70 IT/I. Tlw suoolementation sachets were tration NCT00255385.

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