Oral protein calorie supplementation for children with chronic disease

Damian K Francis, Joanne Smith, Tawab Saljuqi, Ruth M Watling, Damian K Francis, Joanne Smith, Tawab Saljuqi, Ruth M Watling

Abstract

Background: Poor growth and nutritional status are common in children with chronic diseases. Oral protein calorie supplements are used to improve nutritional status in these children. These expensive products may be associated with some adverse effects, e.g. the development of inappropriate eating behaviour patterns. This is a new update of a Cochrane review last updated in 2009.

Objectives: To examine evidence that in children with chronic disease, oral protein calorie supplements alter daily nutrient intake, nutritional indices, survival and quality of life and are associated with adverse effects, e.g. diarrhoea, vomiting, reduced appetite, glucose intolerance, bloating and eating behaviour problems.

Search methods: Trials of oral protein calorie supplements in children with chronic diseases were identified through comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings. Companies marketing these products were also contacted.Most recent search of the Group's Trials Register: 24 February 2015.

Selection criteria: Randomised or quasi-randomised controlled trials comparing oral protein calorie supplements for at least one month to increase calorie intake with existing conventional therapy (including advice on improving nutritional intake from food or no specific intervention) in children with chronic disease.

Data collection and analysis: We independently assessed the outcomes: indices of nutrition and growth; anthropometric measures of body composition; calorie and nutrient intake (total from oral protein calorie supplements and food); eating behaviour; compliance; quality of life; specific adverse effects; disease severity scores; and mortality; we also assessed the risk of bias in the included trials.

Main results: Four studies (187 children) met the inclusion criteria. Three studies were carried out in children with cystic fibrosis and one study included children with paediatric malignant disease. Overall there was a low risk of bias for blinding and incomplete outcome data.Two studies had a high risk of bias for allocation concealment. Few statistical differences were found in the outcomes we assessed between treatment and control groups, except change in total energy intake at six and 12 months, mean difference 304.86 kcal per day (95% confidence interval 5.62 to 604.10) and mean difference 265.70 kcal per day (95% confidence interval 42.94 to 485.46), respectively. However, these were based on the analysis of just 58 children in only one study. Only two chronic diseases were included in these analyses, cystic fibrosis and paediatric malignant disease. No other studies were identified which assessed the effectiveness of oral protein calorie supplements in children with other chronic diseases.

Authors' conclusions: Oral protein calorie supplements are widely used to improve the nutritional status of children with a number of chronic diseases. We identified a small number of studies assessing these products in children with cystic fibrosis and paediatric malignant disease, but were unable to draw any conclusions based on the limited data extracted. We recommend a series of large, randomised controlled trials be undertaken investigating the use of these products in children with different chronic diseases. Until further data are available, we suggest these products are used with caution.

Conflict of interest statement

Original review and updates to 2009

Two of the authors are dietitians (VP, RW) who have received travel expenses to attend conferences from the manufacturers of oral protein calorie supplements.

All three of the authors of this review were involved in the CALICO trial (Poustie 2006).

Subsequent updates

Ruth Watling is a dietitian who has received sponsorship to attend meetings and conferences and honorarium to present lectures at conferences and study days from companies who produce oral protein calorie supplements. She declares that this does not influence the use of such products in her clinical practice where the clinical condition, age and nutritional status of the child in conjunction with the scientific evidence is paramount to her decision making. Ruth Watling was also involved in the CALICO trial (Poustie 2006).

The remaining authors declare no conflict of interest.

Figures

1
1
Study flow diagram for 2015 update.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1. Analysis
1.1. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 1 Change in weight in kg.
1.2. Analysis
1.2. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 2 Change in weight Z score.
1.3. Analysis
1.3. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 3 Change in height in cm.
1.4. Analysis
1.4. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 4 Change in height Z score.
1.5. Analysis
1.5. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 5 Change in body mass index.
1.6. Analysis
1.6. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 6 Change in body mass index Z score.
1.7. Analysis
1.7. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 7 Change in % ideal weight for height.
1.8. Analysis
1.8. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 8 Change in mid‐arm muscle circumference.
1.9. Analysis
1.9. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 9 Change in total energy intake (kcal/day).
1.10. Analysis
1.10. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 10 Change in total fat intake (g/day).
1.11. Analysis
1.11. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 11 Change in total protein intake (g/day).
1.12. Analysis
1.12. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 12 Disease severity score.
1.13. Analysis
1.13. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 13 Gastro‐intestinal symptom score.
1.14. Analysis
1.14. Analysis
Comparison 1 Oral protein calorie supplements compared with no intervention, placebo or additional nutritional advice, Outcome 14 Headache.

References

References to studies included in this review Bayram 2009 {published data only}

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Poustie 2006 {published data only}
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Fell 2000 {published data only}
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INCAP Study {published data only}
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Lloyd‐Still 2006 {published data only}
    1. Lloyd‐Still J, Powers CA, Hoffman DR, Boyd‐Trull K, Lester LA, Benisek DC, et al. A randomized, controlled study examining the bioavailability and safety of an algal docosahexaenoic acid (DHA) triacylglycerol in cystic fibrosis (CF) patients [abstract]. Pediatric Pulmonology 2004;38(Suppl 27):331.
    1. Lloyd‐Still JD, Powers CA, Hoffman DR, Arterburn LM, Benisek DC, Lester LA. Bioavailability and safety of an algal docosahexaenoic acid (DHA) triglyceride in cystic fibrosis (CF) [abstract]. Pediatric Research 2001;49(4 Suppl):455a.
    1. Lloyd‐Still JD, Powers CA, Hoffman DR, Boyd‐Trull K, Arterburn LM, Benisek DC, et al. Blood and tissue essential fatty acids after docosahexaenoic acid supplementation in cystic fibrosis [abstract]. Pediatric Pulmonology 2001;32(Suppl 22):263.
    1. Lloyd‐Still JD, Powers CA, Hoffman DR, Boyd‐Trull K, Lester LA, Benisek DC, et al. Bioavailability and safety of a high dose of docosahexaenoic acid triacylglycerol of algal origin in cystic fibrosis patients: a randomized, controlled study. Nutrition 2006;22(1):36‐46.
    1. Powers CA, Lloyd‐Still JD, Hoffman DR, Arterburn LM, Benisek DC, Lester LA. Lipid soluble antioxidant status during supplementation with algal docosahexaenoic acid triglyceride in CF [abstract]. Proceedings of 24th European Cystic Fibrosis Conference; 2001 June 6‐9; Vienna, Austria. 2001:P133.
Lutter 2008 {published data only}
    1. Lutter CK, Rodriguez A, Fuenmayor G, Avila L, Sempertegui F, Escobar J. Growth and micronutrient status in children receiving a fortified complementary food. Journal of nutrition 2008;138(2):379‐88.
Maes 1997 {published data only}
    1. Maes M, Sokal E, Otte JB. Growth factors in children with end‐stage liver disease before and after liver transplantation: a review. Pediatric Transplantation 1997;1(2):171‐5. [MEDLINE: ]
Mahlungulu 2007 {published data only}
    1. Mahlungulu S, Grobler LA, Visser ME, Volmink J. Nutritional interventions for reducing morbidity and mortality in people with HIV. Cochrane Database of Systematic Reviews 2007, Issue 3. [DOI: 10.1002/14651858.CD004536.pub2]
Manguso 2005 {published data only}
    1. Manguso F, D'Ambra G, Menchise A, Sollazzo R, D'Agostino L. Effects of an appropriate oral diet on the nutritional status of patients with HCV‐related liver cirrhosis: A prospective study. Clinical Nutrition 2005;24(5):751‐9. [PUBMED: 16182039]
Marques 2004 {published data only}
    1. Marques IL, Barros Almeida Peres SP, Bettiol H, Barbieri MA, Andrea M, Souza L. Growth of children with isolated Robin sequence treated by nasopharyngeal intubation: Importance of a hypercaloric diet. Cleft Palete‐Craniofacial Journal 2004;41(1):53‐8. [PUBMED: 14697069]
Martorell 1995 {published data only}
    1. Martorell R, Habicht JP, Rivera JA. History and design of the INCAP longitudinal study (1969‐77) and its follow‐up (1988‐89). Journal of Nutrition 1995;125:1027S‐41S.
Mathisen 1999 {published data only}
    1. Mathisen B, Worrall L, Masel J, Wall C, Shepherd RW. Feeding problems in infants with gastro‐oesophageal reflux disease: a controlled study. Journal of Paediatrics and Child Health 1999;35(2):163‐9. [MEDLINE: ]
McCargar 1998 {published data only}
    1. McCargar LJ, Innis SM, Bowron E, Leichter J, Dawson K, Toth E, et al. Effect of enteral nutritional products differing in carbohydrate and fat on indices of carbohydrate and lipid metabolism in patients with NIDDM. Molecular & Cellular Biochemistry 1998;188(1‐2):81‐9.
McClure 2000 {published data only}
    1. McClure RJ, Newell SJ. Randomised controlled study of clinical outcome following trophic feeding. Archives of Disease in Childhood. Fetal and Neonatal Edition 2000;82(1):F29‐33.
McWhirter 1994 {published data only}
    1. McWhirter JP, Pennington CR. A comparison between oral and nasogastric nutritional supplements in malnourished patients [abstract]. Proceedings of the 5th British Association of Parenteral and Enteral Nutrition Conference. 1995.
Mok 2006 {published data only}
    1. Mok E, Eleouet‐Da VC, Daubrosse C, Gottrand F, Rigal O, Fontan JE, Cuisset JM, Guilhot J, Hankard R. Oral glutamine and amino acid supplementation inhibit whole‐body protein degradation in children with Duchenne muscular dystrophy. American Journal of Clinical Nutrition 2006;83(4):823‐8.
Mora 1981 {published data only}
    1. Mora JO, Herrera MG, Suescun J, Navarro L, Wagner M. The effects of nutritional supplementation on physical growth of children at risk of malnutrition. American Journal of Clinical Nutrition 1981;34(9):1885‐92. [MEDLINE: ]
Ndekha 2005 {published data only}
    1. Ndekha MJ, Manary MJ, Ashorn P, Briend A. Home‐based therapy with ready‐to‐use therapeutic food is of benefit to malnourished, HIV‐infected Malawian children. Acta Paediatrica 2005;94(2):222‐5. [PUBMED: 15981758]
Newby 2007 {published and unpublished data}
    1. Newby EA, Sawczenko A, Thomas AG, Wilson D. Interventions for growth failure in childhood Crohn's disease. Cochrane Database of Systematic Reviews 2007, Issue 1. [DOI: 10.1002/14651858.CD003873.pub2]
Nielson 2007 {published data only}
    1. Nielsen AA, Nielsen JN, Gronbaek H, Eivindson M, Vind I, Munkholm P, Brandslund I. Impact of enteral supplements enriched with omega‐3 fatty acid and/or omega‐6 fatty acids, arginine and ribonucleic acid compounds on leptin levels and nutritional status in active Crohn's disease treated with prednisolone. Digestion 2007;75(1):10‐6.
Oudshoorn 2007 {published data only}
    1. Oudshoorn JH, Klijn PH, Hofman Z, Voorbij HA, Ent CK, Berger R, et al. Dietary supplementation with multiple micronutrients: no beneficial effects in pediatric cystic fibrosis patients. Journal of Cystic Fibrosis 2007;6(1):35‐40.
Papadopoulou 1998 {published data only}
    1. Papadopoulou A. Nutritional considerations in children undergoing bone marrow transplantation. European Journal of Clinical Nutrition 1998;52(12):863‐71. [MEDLINE: ]
Papas 2007 {published data only}
    1. Papas K, Kalbfleisch J, Mohon R. Bioavailability of a novel, water‐soluble vitamin E formulation in malabsorbing patients. Digestive Diseases and Sciences 2007;52(2):347‐52.
Pelekanos 1990 {published data only}
    1. Pelekanos JT, Holt TL, Ward LC, Cleghorn GJ, Shepherd RW. Protein turnover in malnourished patients with cystic fibrosis: Effects of elemental and non elemental nutritional supplements. Journal of Pediatric Gastroenterology & Nutrition 1990;10(3):339‐43.
Powers 1999 {published data only}
    1. Powers SW, Schindler T, Schwarber L, Deeks CM, Byars KC, Arthur S, et al. Behavioral treatment to improve nutrition in toddlers with cystic fibrosis [abstract]. Pediatric Pulmonology 1999;Suppl 19:329.
Powers 2006 {published data only}
    1. Powers SW, Piazza‐Waggoner C, Jones JS, Ferguson KS, Daines C, Acton JD. Examining clinical trial results with single‐subject analysis: an example involving behavioural and nutrition treatment for young children with cystic fibrosis. Journal of Pediatric Psychology 2006;31(6):574‐81.
Raynor 1999 {published data only}
    1. Raynor P, Rudolf MC, Cooper K, Marchant P, Cottrell D. A randomised controlled trial of specialist health visitor intervention for failure to thrive. Archives of Disease in Childhood 1999;80(6):500‐6. [MEDLINE: ]
Reifsnider 1998 {published data only}
    1. Reifsnider E. Follow‐up study of children with growth deficiency. Western Journal of Nursing Research 1998;20(1):14‐29.
    1. Reifsnider E. Reversing growth deficiency in children: the effect of a community‐based intervention. Journal of Pediatric Health Care 1998;12(6 Pt 1):305‐12.
Rettammel 1995 {published data only}
    1. Rettammel AL, Marcus MS, Farrell PM, Sondel SA, Koscil RE, Mischler EH. Oral supplementation with a high‐fat, high‐energy product improves nutritional status and alters serum lipids in patients with cystic fibrosis. Journal of the American Dietetic Association 1996;95:454‐9.
Rickard 1983 {published data only}
    1. Rickard KA, Foland BB, Detamore CM, Coates TD, Grosfeld JL, White NM, et al. Effectiveness of central parenteral nutrition versus peripheral parenteral nutrition plus enteral nutrition in reversing protein‐ energy malnutrition in children with advanced neuroblastoma and Wilm's tumor: A prospective randomized study. The American Journal of Clinical Nutrition 1983;38:445‐56.
Rickard 1984 {published data only}
    1. Rickard KA, Loghani ES, Grosfeld JL, Detamore CM, White NM, Foland BB, et al. Effectiveness of enteral and parenteral nutrition in preventing and/or reversing PEM in children with advanced neuroblastoma: a prospective randomized study [abstract]. Proceedings of the Annual Meeting of the American Society of Clinical Oncologists. 1984.
Rickard 1989 {published data only}
    1. Godshall BJ, Rickard KA, Loghmani ES, Coates TD, Grosfeld JL, Weetman RM, et al. Intergration of nutritional support into oncologic treatment protocols for high and low nutritional risk children with Wilm's tumor: a prospective randomized study [abstract]. Proceedings of the Annual Meeting of the American Society of Clinical Oncologists. 1987. [MEDLINE: ]
    1. Rickard KA, Detamore CM, Coates TD, Grosfeld JL, Weetman RM, White NM, et al. Effect of nutrition staging on treatment delays and outcome in Stage IV neuroblastoma. Cancer 1983;52:587‐98.
    1. Rickard KA, Godshall BJ, Loghmani ES, Coates TD, Grosfeld JL, Weetman RM, et al. Integration of nutrition support into oncologic treatment protocols for high and low nutritional risk children with Wilm's tumour. A prospective randomized study. Cancer 1989;64(2):491‐509.
    1. Rickard KA, Grosfeld JL, Kirksey A, Ballantine TVN, Baehner RL. Reversal of protein energy malnutrition in children during treatment of advanced neoplastic disease. Annals of Surgery 1979;190(6):771‐81.
    1. Rickard KA, Loghmani ES, Grosfeld JL, Detamore CM, White NM, Foland BB, et al. Effectiveness of enteral and parenteral nutrition in preventing and/or reversing PEM in children with advanced neuroblastoma: a prospective randomised study [abstract]. Proceedings of the Annual Meeting of the American Society of Clinical Oncologists. 1984.
    1. Rickard KA, Loghmani ES, Grosfeld JL, Lingard CD, White NM, Foland BB, et al. Short‐ and long‐term effectiveness of enteral and parenteral nutrition in reversing or preventing protein‐energy malnutrition in advanced neuroblastoma A prospective randomised study. Cancer 1985;56(12):2881‐97.
Rock 1999 {published data only}
    1. Rock MJ, Davis L, Marcus M, Lai HC, Douglas J, Kosorok M, et al. Early nutritional intervention in infants with CF [abstract]. Pediatric Pulmonology 1999;Suppl 19:102‐3.
Rollins 2007 {published data only}
    1. Rollins NC, Broeck J, Kindra G, Pent M, Kasambira T, Bennish ML. The effect of nutritional support on weight gain of HIV‐infected children with prolonged diarrhoea. Acta Paediatrica 2007;96(1):62‐8.
Saiyed 2000 {published data only}
    1. Saiyed F, Seshadri S. Impact of the integrated package of nutrition and health services. Indian Journal of Pediatrics 2000;67(5):322‐8.
Shaw 1999 {published data only}
    1. Shaw WC, Bannister RP, Roberts CT. Assisted feeding is more reliable for infants with clefts‐a randomized trial. The Cleft Palate‐Craniofacial Journal 1999;36(3):262‐8.
Shepherd 1988 {published data only}
    1. Shepherd RW, Holt TL, Cleghorn G, Ward LC, Isles A, Francis P. Nutritional supplementation during management of pulmonary exacerbations in CF: a controlled study including effects on protein turnover [abstract]. Proceedings of the 10th International Cystic Fibrosis Congress. 1988.
    1. Shepherd RW, Holt TL, Cleghorn G, Ward LC, Isles A, Francis P. Short‐term nutritional supplementation during management of pulmonary exacerbations in cystic fibrosis: a controlled study, including effects on protein turnover. American Journal of Clinical Nutrition 1988;48(2):235‐9.
Sirisinha 1973 {published data only}
    1. Sirisinha S, Edelman R, Suskind R, Charupatana C, Olsen RE. Complement and C3‐proactive levels in children with protein‐calorie malnutrition and effect of dietary treatment. Lancet 1973; Vol. 1, issue 7811:1016‐20. [MEDLINE: ]
Soliman 2004 {published data only}
    1. Soliman AT, El‐Matary W, Abdel Fattah MM, Nasr IS, Alaily RK, Alaa Thabet M. The effect of high‐calorie diet on nutritional parameters of children with beta‐thalassaemia major. Clinical Nutrition 2004;23(5):1153‐8. [PUBMED: 15380908 ]
Sondel 1987 {published data only}
    1. Sondel SA, Parrell SW, Becker D, Mischler EH. Oral nutritional supplements in cystic fibrosis. Nutrition Support Services 1987;7(4):20‐2.
Stark 2005 {published data only}
    1. Stark LJ, Hommel KA, Mackner LM, Janicke DM, Davis AM, Pfefferkorn M, et al. Randomized trial comparing two methods of increasing dietary calcium intake in children with inflammatory bowel disease. Journal of Pediatric Gastroenterology & Nutrition 2005;40(4):501‐7. [MEDLINE: ]
Taylor 1999 {published data only}
    1. Taylor SJ, Fettes SB, Jewkes C, Nelson RJ. Prospective, randomized, controlled trial to determine the effect of early enhanced enteral nutrition on clinical outcome in mechanically ventilated patients suffering head injury [see comments]. Critical Care Medicine 1999;27(11):2525‐31.
Teixido‐Planas 2005 {published data only}
    1. Teixido‐Planas J, Ortiz A, Coronel F, Montenegro J, Lopez‐Menchero R, Ortiz R, et al. Oral protein‐energy supplements in peritoneal dialysis: A multicentre study. Peritoneal Dialysis International 2005;25(2):163‐72. [PUBMED: 15796145]
van Eys 1982 {published data only}
    1. Eys J, Cangir AC. Effect of nutritional supportive therapy on children with advanced cancer. Cancer Research 1982;42(2 Suppl):713‐4s.
Walker 2000 {published data only}
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Yamamoto 2007 {published data only}
    1. Yamamoto T, Nakahigashi M, Umegae S, Kitagawa T, Matsumoto K. Impact of long‐term enteral nutrition on clinical and endoscopic recurrence after resection for Crohn's disease: A prospective, non‐randomised, parallel, controlled study. Alimentary Pharmacology & Theraputics 2007;25(1):67‐72.
References to ongoing studies Cox 2014 {published data only}
    1. Cox SE, Makani J, Walter G, Mtunguja S, Kamala BA, Ellins E, et al. Ready‐to‐use supplementary food supplements improve endothelial function, hemoglobin and growth in Tanzanian children with sickle cell anaemia: the vascular function intervention study (V‐FIT), a random order crossover trial [abstract]. 56th ASH Annual Meeting and Exposition; 2014 Dec 6‐9; San Francisco, California 2014;1:Abstract no: 4087. [CENTRAL: 1017322; CFGD Register: SC262 ; CRS: 5500131000000279]
Additional references Corey 1988
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CPS 1994
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Curtin 2002a
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Curtin 2002b
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Curtin 2002c
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Egger 1997
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Elbourne 2002
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Florescu 2014
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Hendricks 1995
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Hendrickse 1997
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Higgins 2011
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Johansson 1986
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Joosten 2010
    1. Joosten K F, Zwart H, Hop W C, Hulst J M. National malnutrition screening days in hospitalised children in The Netherlands. Arch Dis Child 2010;95:141‐5.
Koscik 2004
    1. Koscik RL, Farrell PM, Kosorok MR, Zaremba KM, Laxova A, Lai HC, et al. Cognitive function of children with cystic fibrosis: deleterious effect of early malnutrition. Pediatrics 2004;113(6):1549‐58.
Moy 1990
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Pawellek 2008
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RevMan 2014 [Computer program]
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Smyth 2014
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Spagnuolo 2013
    1. Spagnuolo M I, Liguoro I, Chiatto F, Mambretti D, Guarino A. Application of a score system to evaluate the risk of malnutrition in a multiple hospital setting. Ital J Pediatr 2013;39:81.
References to other published versions of this review Poustie 2009
    1. Poustie VJ, Smyth RL, Watling RM. Oral protein calorie supplementation for children with chronic disease. Cochrane Database of Systematic Reviews 2009, Issue 3. [DOI: 10.1002/14651858.CD001914]

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