Fernleaf 1+ with Nutri-care™ Proven to Protect Against Common Childhood Illness

Summary

• A recent, large-scale study has shown that consumption of Fernleaf 1+ with Nutricare™ (also known as Anchor 1+ with Nutricare in some countries), a fortified milk powder for children,improved the health of children by significantly reducing the incidence and duration of common childhood illnesses.
• The study, led by eminent researcher Professor Sunil Sazawal, was a randomised, controlled, double blind, community-based intervention involving one year of supplementation with Fernleaf 1+ with Nutricare™ to children aged 1-3 years.
• The nutrients used for fortification were zinc, iron, vitamins A, C and E, selenium and copper for their anti-oxidant and immuno-modulatory properties.
• Milk is a sustainable vehicle for delivering fortification to children due to its wide availability and acceptance.
• The study results have relevance to children throughout Asia and the Middle East as nutritional deficiencies and related childhood sicknesses from pneumonia and diarrhoea are a major concern across these regions.

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The Study

A recent study, published in the British Medical Journal,¹ has shown that fortification of Fernleaf 1+ milk with Nutricare™ is a practical intervention to improve the health among children 1-3 years significantly by reducing the incidence of common childhood sicknesses. The study was led by principal investigator Professor Sunil Sazawal, who has more than 15 years of experience internationally in Pediatric trials and is well respected in this field. His team of researchers were highly skilled and have undertaken many important research projects including work for the World Health Organisation (WHO) and two National Institutes of Health (NIH-ROI) studies.

The study was specifically designed to meet a high standard for clinical research trials and therefore contained the following characteristics:

• Double blind to ensure there was no bias in the results
• Controlled to remove any "placebo effect"
• Individually randomized
• Large scale - 633 children aged 1-3 years, this was calculated as the sample size necessary to attain statistically significant results
• Reproducible

The Intervention

The population in which the study was undertaken in was a peri-urban population living in well-constructed homes. All participants in the study received the study milk powders packaged in single serve sachets with advice to consume two to three sachets reconstituted (using previously boiled and cooled water) per day for one year. The intervention group received  Fernleaf 1+ with Nutricare™  (milk powder that had been fortified with zinc, iron, selenium, copper and vitamins A, C and E). Table 1 shows the level of each nutrient per serve in Fernleaf 1+ with Nutricare™ . The control group received the same base milk powder without the fortification, therefore had natural levels of these nutrients as typically found in milk.

Zinc was added to the intervention formulation because of its key role in the immune system and its importance for growth and development. Likewise, Iron was added for its role in growth and development and for preventing iron deficiency anemia. The fortified milk also contained vitamin C to aid iron absorption and copper to counteract possible effects of increased zinc and iron on copper absorption. Selenium, vitamin A and vitamin E were also added as co-factors to zinc in anti-oxidant and immune effect.

Table 1:  Levels of Nutrients per Serve in Fernleaf 1+ with Nutricare™

Why use Fortified Milk?

The study was conducted using milk as a vehicle for delivering fortification. Whole milk is a staple in the diets of most young children. It is a very important component in their diet as it is a nutritious food in its own right providing a good source of energy, protein and fat plus a range of vitamins and minerals naturally available before fortification, in particular, calcium and vitamin A.

There were several reasons for using milk as the vehicle to deliver the nutrients:

• Milk is widely available and economical when compared with, for example, supplements, and is a commonly used food in the home.
• Children are familiar with milk, like the taste of it and find it easy to ingest compared with supplements, which means the compliance is higher. There are also fewer side effects from taking fortified food compared with taking supplements.
• Milk has been used effectively in previous studies as a vehicle for delivering nutrients. In particular, iron fortified milk has had greater success than the iron supplementation approach. Iron supplementation, although technically feasible, has not been successful due to problems with delivery and compliance.² Several studies have shown that milk fortified with iron is effective in preventing and correcting iron deficiency and anemia and has high acceptance and tolerance amongst children aged 6 months to 4 years.^3,4,5,6,7

The Results from the Study

The study measured episodes of diarrhea and acute lower respiratory tract infection (ALRI) (e.g. pneumonia) and days of febrile and severe illness. The results showed that in children aged 1-3 years the consumption of Fernleaf 1+ with Nutricare™ compared to the same milk unfortified resulted in an 18% reduction in incidence of diarrhea and a similarly lower prevalence of diarrhea. The incidence of ALRI was 26% lower in the Fernleaf 1+ with Nutricare™ group than the control and the total number of days with the respiratory rate - 40/ min was reduced by 25%. Fernleaf 1+ with Nutricare™ also reduced the incidence of severe illness by 15% and high temperature by 7%. There was a 4 % reduction in antibiotics usage by the Fernleaf 1+ with Nutricare™ group.

Of particular interest was the analysis by age group. In the children aged 1-2 years the reduction in incidence of ALRI in those taking Fernleaf 1+ with Nutricare™ was 47% and the reduction in severe illness was 36%. In children aged 2-3 years the reduction in incidence of diarrhoea was 20%.

Table 2 shows the results for each outcome and includes the analysis for children 1-2 years versus 2-3 years.

 Table 2:  Effect of Intervention on Morbidity 

*Odds ratios

Table adapted from Sazawal et al, 2006¹

Relevance of Study Findings

These results hold great importance and relevance not only to children in India but also to those throughout the Asian and Middle Eastern regions. Studies across these regions have shown that there are nutrient deficiencies, diarrheal and respiratory morbidity issues in children similar to those in the study population. For this reason, there is high transferability of results to other countries in these regions.

Micronutrient deficiencies, especially iron deficiency, are widespread amongst children in many countries. Due to similar issues in absorption and bioavailability, zinc and iron deficiency usually go hand in hand. Previous zinc supplementation studies have shown positive health benefits in a variety of populations and settings throughout the world.^{8,9,10,11,12,13} Three meta-analyses of trials evaluating the effects of zinc supplementation, all show substantial reduction in rates of diarrhea and pneumonia.^11,12,13

In Malaysia, studies indicate that mild to moderate under nutrition is a problem, with children in rural areas at particular risk.^14,15,16,17 Moderately high prevalence of iron-deficiency anemia has been reported,^16,18,19,20 and diarrheal disease is seen as an important health problem causing high morbidity and mortality with consequent retardation in growth and development.²¹ A large-scale community based survey of 12,273 children under seven found that 30% had experienced acute respiratory infection (ARI) in the past 2 weeks. ²²

Diarrhea and pneumonia are also leading causes of child mortality in the Philippines with reports that up to 12,500 Filipino children under 5 years are dying from dehydration caused by diarrhea each year ²³ and the pneumonia rate is 38% in children 1-4 years.²⁴ In Singapore, the KKH hospital reported there were 7.5 ALRI admissions per 1000 for the below five age group in 1999.²⁵

The WHO reports approximately 30% of children under five years are underweight ²⁶ and one third of children in Sri Lanka suffer from some form of malnutrition.²⁷ A recent, large-scale study of 2,248 children less than five years of age in 60 villages in rural Sri Lanka reported diarrhea prevalence of 14.8% and ARI prevalence of 82%.²⁸ Strategies to reduce the need for antibiotics would be valuable, as 47% of children with possibly non-bacterial ARI had been unnecessarily prescribed antibiotics. ²⁹

There are similar trends and issues in the Middle East. In Egypt, seasonally adjusted diarrhoea incidence is reported at 3.6 episodes per child under five years of age per year. This means a minimum estimate of 30 million cases annually in Egypt³⁰ and a recent study in Saudi Arabia reported prevalence of ARI was 24% in children under 2 years old. ³¹

It is concluded that mortality from diarrhea and pneumonia is a widespread problem throughout Asian and Middle Eastern countries. The consumption of Fernleaf 1+ with Nutricare™ is associated with a reduced incidence of diarrhea, ALRI and days with severe illness and therefore an improvement in children's health. Fernleaf 1+ with Nutricare™  fortified milk is well accepted and sustainable as an intervention to deliver these nutrients to children. 

References

 1.      Sazawal S, Dhingra U, Hiremath G, Kumar J, Dhingra P, Sarkar, A, Venugopal M, Black RE. Effects of fortified milk on morbidity in young children in north India: community based, randomized, double masked placebo controlled trial. BMJ, 2006; doi:10.1136/bmj.39035.482396.55

2.      Ahluwalia N. Intervention strategies for improving iron status of young children and adolescents in India. Nutr Rev 2002;60(5 Pt 2):S115-7.

3.      Rapetti, M., et al., Correction of iron deficiency with an iron-fortified fluid whole cow's milk in children: results of a pilot study. Journal of Pediatric Hematology / Oncology, 1997. 19(3): p. 192-196.

4.      Gill, D., S. Vincent, and D. Segal, Follow-on formula in the prevention of iron deficiency: a multicentre study. Acta Paediatr, 1997. 86: p. 683-9.

5.      Williams, J., et al., Iron supplemented formula milk related to reduction in psychomotor decline in infants from inner city areas: randomised study. BMJ, 1999. 318: p. 693-8.

6.      Morley, R., et al., Iron fortified follow-on formula from 9 to 18 months improves iron status but not development or growth: a randomised trial. Arch Dis Child, 1999. 81: p. 247-252.

7.      Iost, C., et al., Repleting haemoglobin in iron deficiency anaemia in young children through liquid milk fortification with bioavailable iron amino acid chelate. Journal of the American College of Nutrition, 1998. 17(2): p. 187-194.

8.      Sazawal, S., et al., Zinc supplementation reduces the incidence of acute lower respiratory infections in infants and preschool children: a double-blind, controlled trial. Pediatrics, 1998. 102: p. 1-5.

9.      Sazawal, S., et al., Zinc supplementation in infants born small for gestational age reduces mortality: A prospective, randomized, controlled trial. Pediatrics, 2001; 108: p. 1280-1286

10.  Sazawal, S., et al., Zinc supplementation for four months does not affect plasma copper concentration in infants. Acta Paediatr, 2004. 93: p. 599-602.

11.  Bhutta, Z., et al., Prevention of diarrhoea and pneumonia by zinc supplementation in children in developing countries: pooled analysis of randomized controlled trials. J Pediatr, 1999. 135: p. 689-97.

12.  Bhutta, Z., et al., Therapeutic effects of oral zinc in acute and persistent diarrhea in children in developing countries: pooled analysis of randomized controlled trials. Am J Clin Nutr, 2000. 72: p. 1516-22.

13.  Sazawal, S. and P. Malik, Preventing zinc deficiency in early infancy: impact on morbidity, growth and mortality. Nestle Nutrition Workshop Series Paediatric Progam, 2003. 52: p. 143-163.

14.  Marjan ZM, Taib MNM, Lin KG, Siong TE. Socio-economic determinants of nutritional status of children in rural peninsular Malaysia. Asia Pacific J Clin Nutr 1998; 7(3/4): p. 307-310.

15.  Ali O, Isa ZM. Nutritional status of women and children in Malaysian rural populations. Asia Pacific J Clin Nutr 1995; 4: p. 319-333.

16.  Zalilah MS, et al. Food security and child nutritional status among Orang Asli (Temuan) households in Hulu Langat, Selangor. Med J Malaysia 2002; 57: p. 36-50.

17.  Gan CY, et al. Nutritional status of Kadazan children in rural district Sabah, Malaysia. Southeast Asian Journal of Tropical Medicine and Pubic Health. 1993; 24 (2):p. 293-301.

18.  Foo LH, et al. Iron status and dietary iron intake of adolescents from a rural community in Sabah, Malaysia. Asia Pacific J Clin Nutr 2004; 13(1): p. 48-55.

19.  Coordinating Committee for the Preparation of the FAO/WHO International Conference on Nutrition ICN. Malaysia Country Paper for the FAO/WHO International Conference on Nutrition, Rome, 1992.

20.  Norhayati M, et al. Nutrient intake and socio-economic status among children attending a health exhibition in Malaysian rural villages. Med J Malaysia 1995; 50(4): p. 382-390.

21.  Barker RA, et al. Paediatric gastroenteritis in the eastern Malaysian state of Sarawak: an epidemiological and clinical study. Transactions of the Royal Society of Tropical Medicine and Hygiene 1988; 82: p. 898-901.

22.  Lye MS, et al. Acute respiratory infection in Malaysian children. Journal of Tropical Pediatrics 1994; 40(4):. 334-340.

23.  Easton, A. Philippine plan to cut diarrhoea deaths. BMJ, 1999; 319(*):75

24.  Department of Health, Philippines http://www.doh.gov.ph/data_stat/html/child_mort.htmhttp://www.doh.gov.ph/data_stat/html/keyindicator.htm#cmch  Accessed 1st December 2006

25.  Yin CC, Huah LW, Lin JT, Goh A, Ling HJ, Moh CO. Lower respiratory tract infection in hospitalized children. Respirology, 2003; 8(1):83-9

26.  WHO (2000). Nutrition in South East Asia, 9-10.

27.  De Silva A, Atukorala S, Ahluwalia N (2004). Dietary intake of macro and micronutrients in children: does recurrent illness reduce intake? Asia Pac J Clin Nutr, 13 (Suppl):S119

28.  De Silva KSH, Fernando S, Gajamange SFN, et al (2001). An audit on the use of antibiotics in watery/mucoid diarrhea at admission to hospital. Sri Lankan Journal of Child Health, 30:28-30.

29.  Lucas MN, Liyanage UA, Lokukankanamage LKUI (2001). A study of antibiotic usage in acute respiratory infections in children. Sri Lankan Journal of Child Health, 30:5-7.

30.  Jousilahti P, Madkopur SM, Lambrechts T, Sherwin E (1997). Diarrhoeal disease morbidity and home treatment practices in Egypt. Public health 111(1):5-10

31.  Saeed AA, Bani IA. (2000). Prevalence and correlates of acute respiratory infections in children less than two years of age. Saudi Med J;21(2):1152-6.