A double-blind, placebo-controlled randomized trial to evaluate the efficacy of docosahexaenoic acid supplementation on hepatic fat and associated cardiovascular risk factors in overweight children with nonalcoholic fatty liver disease

Pacifico, Lucia; Bonci, Enea; Martino, Michele Di; Versacci, Paolo; Andreoli, G; Silvestri, Lucia Martina; Chiesa, Claudio

doi:10.1016/j.numecd.2015.04.003

Cited by 88 publications

(113 citation statements)

References 33 publications

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“…There was no difference in average adherence between those two methods of supplementation (M = 87.3%, SD = 9.4 vs. M = 87.6%, SD = 7.8). Fifteen studies, reporting adherence, mentioned talking to parents or participants either via telephone or face to face (or via e-mail) during the study about the supplementation to increase adherence [61,67,69,70,72,90,91,107,111,113,131,134,135,136,143]. The studies that included a phone call did not have a higher average adherence rate (M = 81.5%, SD = 9.5) than those that did not include a phone call (M = 86.2%, SD = 10.3).…”

Section: Resultsmentioning

confidence: 99%

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A Review of Recruitment, Adherence and Drop-Out Rates in Omega-3 Polyunsaturated Fatty Acid Supplementation Trials in Children and Adolescents

2017

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Introduction: The influence of n-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation on health outcomes has been studied extensively with randomized controlled trials (RCT). In many research fields, difficulties with recruitment, adherence and high drop-out rates have been reported. However, what is unknown is how common these problems are in n-3 LCPUFA supplementation studies in children and adolescents. Therefore, this paper will review n-3 LCPUFA supplementation studies in children and adolescents with regard to recruitment, adherence and drop-out rates. Methods: The Web of Science, PubMed and Ovid databases were searched for papers reporting on RCT supplementing children and adolescents (2–18 years) with a form of n-3 LCPUFA (or placebo) for at least four weeks. As a proxy for abiding to CONSORT guidelines, we noted whether manuscripts provided a flow-chart and provided dates defining the period of recruitment and follow-up. Results: Ninety manuscripts (reporting on 75 studies) met the inclusion criteria. The majority of the studies did not abide by the CONSORT guidelines: 55% did not provide a flow-chart, while 70% did not provide dates. The majority of studies provided minimal details about the recruitment process. Only 25 of the 75 studies reported an adherence rate which was on average 85%. Sixty-five of the 75 studies included drop-out rates which were on average 17%. Conclusion: Less than half of the included studies abided by the CONSORT guidelines (45% included a flow chart, while 30% reported dates). Problems with recruitment and drop-out seem to be common in n-3 LCPUFA supplementation trials in children and adolescents. However, reporting about recruitment, adherence and dropout rates was very heterogeneous and minimal in the included studies. Some techniques to improve recruitment, adherence and dropout rates were identified from the literature, however these techniques may need to be tailored to n-3 LCPUFA supplementation studies in children and adolescents.

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Section: Resultsmentioning

confidence: 99%

“…There were three studies that provided some form of incentive [98,107,146], however only one of these studies reported an adherence percentage. Forty-six studies mentioned that they took either blood or cheek samples, but only five studies mentioned that they used blood as an adherence measure [61,85,86,117,134]. …”

Section: Resultsmentioning

confidence: 99%

A Review of Recruitment, Adherence and Drop-Out Rates in Omega-3 Polyunsaturated Fatty Acid Supplementation Trials in Children and Adolescents

2017

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“…The primary outcome was change in HFF measured by MRS, which decreased significantly more in the group receiving DHA versus placebo (14.0% to 6.5% vs 15.5% to 12.0%). Serum ALT also decreased significantly in the DHA group, but this was not different when compared to placebo [40]. …”

Section: Dietary Supplementsmentioning

confidence: 99%

Lifestyle Interventions Including Nutrition, Exercise, and Supplements for Nonalcoholic Fatty Liver Disease in Children

2016

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Nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver disease among children. Lifestyle interventions, such as diet and exercise, are frequently recommended. Children with NAFLD have a distinct physiology that is different from obesity alone and has the potential to influence lifestyle treatments. Studies of diet alone in the treatment of pediatric NAFLD have focused on sugar and carbohydrate, but did not indicate any one dietary approach that was superior to another. For children who are obese and have NAFLD, weight loss may have a beneficial effect regardless of the diet used. Exercise is widely believed to improve NAFLD because a sedentary lifestyle, poor aerobic fitness, and low muscle mass are all risk factors for NAFLD. However, there have been no randomized controlled trials of exercise as a treatment for children with NAFLD. Studies of the combination of diet and exercise suggest a potential for improvement in serum alanine aminotransferase activity and/or magnetic resonance imaging liver fat fraction with intervention. There is also enthusiasm for the use of dietary supplements, however, studies in children have shown inconsistent effects of vitamin E, fish oil, and probiotics. This review presents the available data from studies of lifestyle intervention and dietary supplements published to date, and highlights challenges that must be addressed in order to advance the evidence base for the treatment of pediatric NAFLD.

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“…In a phase 2 double-blind, randomized, placebo-controlled trial, treatment with low-dosage (1800 mg/day) or high-dosage (2700 mg/day) ethyl-eicosapentanoic acid for 12 months had no significant effects on the histologic features of NASH 137 . In contrast, others have shown a benefit of n-3 PUFA treatment on liver fat assessed by magnetic resonance imaging (and have suggested that a greater benefit in NAFLD was associated with docosahexanoic acid treatment) [138][139][140] . Additionally, it has been suggested that the PNPLA3 148MM may attenuate any beneficial effect conferred by n-3 PUFA treatment in NAFLD 141 , emphasizing that future clinical trials testing new potential treatments for NAFLD should also perhaps consider the influence of different genotypes to modify any treatment effect.…”

Section: Management and Treatment Options For Nafldmentioning

confidence: 91%

Non-alcoholic fatty liver disease: an emerging driving force in chronic kidney disease

2017

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A double-blind, placebo-controlled randomized trial to evaluate the efficacy of docosahexaenoic acid supplementation on hepatic fat and associated cardiovascular risk factors in overweight children with nonalcoholic fatty liver disease

Cited by 88 publications

References 33 publications

A Review of Recruitment, Adherence and Drop-Out Rates in Omega-3 Polyunsaturated Fatty Acid Supplementation Trials in Children and Adolescents

A Review of Recruitment, Adherence and Drop-Out Rates in Omega-3 Polyunsaturated Fatty Acid Supplementation Trials in Children and Adolescents

Lifestyle Interventions Including Nutrition, Exercise, and Supplements for Nonalcoholic Fatty Liver Disease in Children

Non-alcoholic fatty liver disease: an emerging driving force in chronic kidney disease

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