First large scale clinical trial on a fortified milk shows significant prevention of childhood diseases

First large scale clinical trial on a fortified milk shows significant prevention of childhood diseases
July 8, 2004

Study on fortified milks could greatly impact the global burden of childhood diseases.

The world's first-ever large-scale clinical study on children's milk has proven that leading childhood diseases such as diarrhoea and pneumonia can be prevented by feeding children a milk fortified with a specific combination of nutrients. These groundbreaking results come from the world's first rigorously designed, large-scale clinical trial investigating the health effects of a milk powder in young children aged one to four years.

The extensive landmark trial, involving over 1,200 children supplemented over a 12-month period, was funded and supported by New Zealand Milk, a world leader in milk products that enhance children's health and nutrition. The study comprised two trial arms; one arm of the study investigated the health benefits of a children's milk fortified with, or without, a complex bundle of vitamins and minerals; the other arm investigated the health benefits of a milk fortified with or without a probiotic ("good" or "beneficial" bacteria) and prebiotics (substances that promote the growth of beneficial good bacteria in the body).

Unveiling the results at a press briefing during the prestigious World Congress of Pediatric Gastroenterology, Hepatology and Nutrition, lead researcher Professor Sunil Sazawal, Associate Research Professor at the Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, USA, and Director at the Center for Micronutrient Research, Annamalai University, India, said,

"This is the first time a study of this size has been conducted to evaluate the effects of specific fortifications of milk on growth and morbidity in young children. The study is unique and important in two particular aspects. Firstly, in terms of overall high quality design, which included adequate sample size, block randomisation, complete double blinding and conservative evaluation with both the groups receiving the same basic milk powder and therefore calories and protein. It sets new benchmarks for proving the health claims made on children's milk.

"Secondly, it has provided clinical evidence that particular fortified milks can greatly impact on prevention of anaemia, burden of common acute illnesses in childhood and their growth. These findings will have importance for child health globally." Findings show fortified milk can prevent major causes of death and sickness in children

In the first arm of the study, children who consumed the milk fortified with a complex bundle of vitamins and minerals, including Vitamins A, C, E and minerals iron, zinc and selenium, were significantly better protected against diarrhoeal episodes and acute lower respiratory infections (such as pneumonia) compared to children who consumed a milk powder containing natural levels of the same nutrients.

Such findings will have a significant global impact on children's health. According to the World Health Organization, diarrhoeal disease is a leading cause of sickness and death globally among children aged two years and below.

Diarrhoea, or watery stools, can lead to the excessive loss of water in children, causing dehydration, which may prove fatal. Loss of nutrients through diarrhoea can also cause children to become weak and malnourished, affecting their physical growth and lowering their body's resistance to diseases.

Acute respiratory infection (ARI), which includes diseases such as pneumonia, is another leading cause of deaths worldwide in young children. In 2000, ARI killed approximately two million children under the age of five in developing countries alone (UNICEF Statistics, June 2004).

The results showed that children consuming the milk powder fortified with the bundle of vitamins and minerals were

• 22 per cent better protected against diarrhoea

• 18 per cent better protected against acute lower respiratory infections and 32 per cent better protected against severe respiratory infections

The milk powder fortified with vitamins and minerals was

• 3.42 times more effective in preventing the development of anaemia (both moderate and severe anaemia).

Children consuming the milk powder fortified with vitamins and minerals were

• 74 per cent better protected against the development of moderate anaemia

• 87 per cent better protected against the development of severe anaemia

The milk powder fortified with vitamins and minerals was shown to:

• Significantly increase iron stores and improve iron status with a 71 per cent reduction in prevalence of sub-optimal iron status and an 86 per cent reduction in the number of children with highly depleted iron stores

• Significantly improve growth - the observed growth patterns for weight and height became closer to the growth charts published by the National Center for Health Statistics (NCHS), USA, widely regarded as the international standard for children

All results reported have been made in comparison to children consuming the corresponding control milk powder.

In the second arm of the study, children who consumed milk powder fortified with the patented probiotic strain Bifidobacterium lactis HN019 (known commercially as DR10TM) and prebiotics (milk-oligosaccharides) were significantly better protected from dysentery (bloody diarrhoea) compared with children who consumed growing up milk powder without the prebiotics and probiotic.

The results showed that children consuming the milk powder fortified with the prebiotics and probiotic Bifidobacterium lactis HN019 (DR10TM) were:

• 22 per cent better protected against dysentery

Consistent with improved immunity, children drinking the milk powder fortified with the prebiotics and probiotic Bifidobacterium lactis HN019 (DR10TM) were:

• 16 per cent better protected against the burden of severe illness (non-diarrhoeal disease) and 32 per cent better protected against sickness with high temperature

• 7 per cent better protected against ear infection

• 6 per cent less likely to need antibiotics

The milk powder fortified with the prebiotics and probiotic Bifidobacterium lactis HN019 (DR10TM) was shown to:

• Significantly improve growth - the observed growth patterns for weight became closer to the growth charts published by National Center for Health Statistics (NCHS), USA, widely regarded as the international standard for children

A clinically meaningful reduction in iron deficiency anaemia of 35 per cent was also observed in the group of children drinking the milk powder fortified with the prebiotics and probiotic Bifidobacterium lactis HN019 (DR10TM).

All results reported have been made in comparison to children consuming the corresponding control milk powder.

Marking a milestone in growing up milk research

The study marks a milestone in the milk industry by being the first clinical trial of its scale and design on growing up milk powders for young children. Unlike most other trials on milk, this study adhered strictly to international accepted criteria used for rigorous clinical human health research trials. Conducted on 1,272 children aged 12 to 36 months, it was designed as a randomised, controlled, double blind (RCDB) trial - a study design that is acknowledged to provide a very high level of evidence when evaluating the efficacy of an intervention or a product, and typically used by the pharmaceutical industry to test new medicines rather than in the food industry. RCDB studies are considered the gold standard in intervention trials for health benefits.

The children were randomly assigned to one of four groups. 1. Children received milk fortified with prebiotics (milk-oligosaccharides) and a probiotic strain Bifidobacterium lactis HN019 (DR10TM) (intervention)

2. Children received the same milk without the added prebiotics or probiotic (control)

3. Children received milk fortified with vitamins and minerals including vitamins A, C, E and minerals iron, zinc and selenium (intervention)

4. Children received the same milk with natural levels of these vitamins and minerals (control).

Children consumed a minimum of two glasses of milk each day for 12 months.

For the duration of the entire study, neither the researchers, the children nor their families knew which group the children were assigned to (double blind), preventing any bias from being introduced into either the assessment of health status or in the analysis of the results.

The study was conducted on children from a lower-middle-class residential area in Sangam Vihar, India, which has a high level of literacy and employment. Prior to enrolment into the study the children underwent health checks by doctors, so that only children who were healthy and had no chronic illnesses were enrolled into the study.

The 12-month study was conducted by a team of internationally renowned researchers in child nutrition led by Professor Sunil Sazawal, Associate Research Professor at Johns Hopkins School of Public Health, Johns Hopkins University, Baltimore, USA. He is widely regarded as an expert in child nutrition.

An external safety monitoring group was commissioned to provide objective advice on issues of safety throughout the trial, ensuring that the children's health and safety came first at all times.

An International Expert Advisory Committee reviewed the study design, undertook site visits to review implementation of the protocol and finally reviewed the analysis and interpretation of the final results.

Professor Geoff Cleghorn, Associate Professor and Head of Department of Paediatrics and Child Health, University of Queensland, who is also on the trial's expert advisory committee, said, "It is refreshing to see such a large-scale clinical trial of a growing up milk powder being designed and conducted to the same rigorous standards used in pharmaceutical drugs trials. We are definitely excited about these very positive findings, which support the use of daily consumption of milk as one accessible way of practically preventing childhood disease worldwide. It also sets a standard for future clinical research on children's milk."

According to Professor Cleghorn, the study commissioned by New Zealand Milk provides substantial evidence of the health benefits of a specially fortified children's milk.

Donna Le Quesne, Global Health and Nutrition Platforms Manager, New Zealand Milk, said, "Parents deserve the assurance that the health claims of the products they choose for their children are supported by clinical evidence based on extensive trials. Right now, consumers have expressed concern at the gamut of health claims on children's milk products and the varying standards of evidence that back these claims.

"New Zealand Milk is committed to putting our products through the most rigorous research before making health claims. Through this study, we hope to set a benchmark in children's health and nutrition," she said.

About New Zealand Milk

New Zealand Milk is a world leader in children's health and nutrition, with more than 50 years of experience under its brands. Set up as part of the New Zealand Dairy Board initially, New Zealand Milk was established in 2001 as a separate company under the ownership of Fonterra Cooperative Group, the company responsible for 95 per cent of milk produced in New Zealand.

New Zealand Milk's brands http://www.newzealandmilk.com/brands, such as ANCHOR, FERNLEAF, ANLENE and ANMUM are well known to consumers and have been providing high quality nutrition in households for several generations. New Zealand Milk is reputed for its quality products globally, including throughout Asia, the Middle East, New Zealand and Australia.

New Zealand Milk's vision is to provide people with products that contain the nutritional components vital for a healthy and active life.

For more information, please visit http://www.newzealandmilk.com