Caracterização de lactentes suplementados com DHA: a pesquisa clínica e suas dificuldades
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Data
2024-02-27
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Universidade Estadual Paulista (Unesp)
Resumo
Introdução: Os ácidos graxos poli-insaturados de cadeia longa (AGPICL), tais como os da família n-3, como o ácido eicosapentaenoico (EPA) e o ácido docosahexaenoico (DHA), têm funções fisiológicas e bioquímicas
relevantes no metabolismo e na saúde humana. O DHA é presente em quantidades importantes quase exclusivamente em frutos do mar (peixes, mariscos, micro e macroalgas), e é um nutriente fundamental para o
crescimento e desenvolvimento (DNPM) infantil por seu papel na formação e no funcionamento do sistema nervoso central e da retina. A deficiência de AGPICLs pode levar ao comprometimento do desempenho cognitivo e comportamental dos lactentes. A pesquisa clínica é um desafio e quando inserida na Atenção Primária em Saúde (APS), no SUS, torna-se ainda mais desafiadora.
Objetivo: Este estudo objetivou avaliar os efeitos da suplementação de DHA extraído de alga marinha em lactentes nos primeiros dois anos de vida, em relação ao desenvolvimento psicomotor e o estado nutricional e, identificar pontos relevantes sobre o desenvolvimento de uma pesquisa clínica na APS. Método: Estudo Caso-Controle, realizado em duas Unidades Básicas de Saúde de Botucatu - Centro de Saúde Escola de Botucatu (CSE), em 2022-23, com coleta de dados do nascimento, bem como o uso de medicações/suplementos; recordatório alimentar, uso de aleitamento materno, ou de fórmula infantil ou leite fluido; avaliação antropométrica com cálculo de IMC e classificação nutricional; e avaliação do DNPM. Iniciou-se a administração do suplemento DHAlga® e avaliação da aceitabilidade do produto. Identificação os desafios enfrentados no trabalho de pesquisa. Projeto aprovado pelo Comitê de Ética em Pesquisa da FMB-UNESP.
Resultados: Foram incluídos 34 lactentes de ambos os sexos, entre um mês e 9,2 meses de idade, a média do peso ao nascimento foi de 3,21 kg (dp=0,62), e a média do peso no momento de inclusão no estudo foi de 6,18 kg, (dp=1,35). Os desafios enfrentados nos trabalhos de pesquisa foram levantados e abordados criticamente no produto técnico. O teste de análise sensorial e avaliação da aceitabilidade do suplemento demonstrou palatibilidade ruim para a faixa etária do estudo. A pesquisa clinica na APS foi um desafio levando ao término antecipado do estudo clínico.
Considerações finais: São pontos relevantes e serem considerados em uma pesquisa clinica: o seguimento fiel aos critérios de inclusão/recrutamento, o apoio contínuo de uma equipe multiprofissional, a vigilância às etapas da pesquisa e o monitoramento dos incluidos.
Introduction: Long-chain polyunsaturated fatty acids (LC-PUFAs), such as those from the n-3 family, like eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), play significant physiological and biochemical roles in human metabolism and health. DHA is predominantly found in substantial amounts in seafood (fish, shellfish, micro, and macroalgae), and it is a crucial nutrient for infant growth and development (DNPM) due to its role in the formation and functioning of the central nervous system and retina. Deficiency in LC-PUFAs can lead to cognitive and behavioral impairments in infants. Clinical research is challenging, and when integrated into Primary Health Care (PHC), in the Unified Health System, it becomes even more complex. Objective: This study aimed to evaluate the effects of DHA supplementation extracted from marine algae in infants during the first two years of life, regarding psychomotor development and nutritional status, and to identify relevant points about the development of clinical research in PHC. Method: A Case-Control study conducted in two Basic Health Units in Botucatu - Botucatu Health School Center (CSE), in 2022-23, collecting data from birth, medication/supplement use; dietary recall, breastfeeding, or use of infant formula or fluid milk; anthropometric assessment with BMI calculation and nutritional classification; and evaluation of DNPM. The administration of the DHAlga® supplement and product acceptability assessment were initiated. Identifying the challenges faced in the research work.The project was approved by the Research Ethics Committee of FMBUNESP. Results: A total of 34 infants of both genders, aged between one month and 9.2 months, were included. The mean birth weight was 3.21 kg (SD=0.62), and the mean weight at the time of study inclusion was 6.18 kg (SD=1.35). The challenges faced in the research work were identified and critically addressed in the technical output. The sensory analysis test and assessment of supplement acceptability demonstrated poor palatability for the study's age group. Clinical research in PHC was a challenge, leading to the premature termination of the clinical study. Conclusion: Key points to be considered in clinical research include faithful adherence to inclusion/recruitment criteria, continuous support from a multidisciplinary team, vigilance in research stages, and monitoring of study participants.
Introduction: Long-chain polyunsaturated fatty acids (LC-PUFAs), such as those from the n-3 family, like eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), play significant physiological and biochemical roles in human metabolism and health. DHA is predominantly found in substantial amounts in seafood (fish, shellfish, micro, and macroalgae), and it is a crucial nutrient for infant growth and development (DNPM) due to its role in the formation and functioning of the central nervous system and retina. Deficiency in LC-PUFAs can lead to cognitive and behavioral impairments in infants. Clinical research is challenging, and when integrated into Primary Health Care (PHC), in the Unified Health System, it becomes even more complex. Objective: This study aimed to evaluate the effects of DHA supplementation extracted from marine algae in infants during the first two years of life, regarding psychomotor development and nutritional status, and to identify relevant points about the development of clinical research in PHC. Method: A Case-Control study conducted in two Basic Health Units in Botucatu - Botucatu Health School Center (CSE), in 2022-23, collecting data from birth, medication/supplement use; dietary recall, breastfeeding, or use of infant formula or fluid milk; anthropometric assessment with BMI calculation and nutritional classification; and evaluation of DNPM. The administration of the DHAlga® supplement and product acceptability assessment were initiated. Identifying the challenges faced in the research work.The project was approved by the Research Ethics Committee of FMBUNESP. Results: A total of 34 infants of both genders, aged between one month and 9.2 months, were included. The mean birth weight was 3.21 kg (SD=0.62), and the mean weight at the time of study inclusion was 6.18 kg (SD=1.35). The challenges faced in the research work were identified and critically addressed in the technical output. The sensory analysis test and assessment of supplement acceptability demonstrated poor palatability for the study's age group. Clinical research in PHC was a challenge, leading to the premature termination of the clinical study. Conclusion: Key points to be considered in clinical research include faithful adherence to inclusion/recruitment criteria, continuous support from a multidisciplinary team, vigilance in research stages, and monitoring of study participants.
Descrição
Palavras-chave
Lactentes, Ácido docosahexaenoico (DHA), Nutrição, Desenvolvimento neuropsicomotor, Relatório de pesquisa
Como citar
MAGALHÃES, P. R. Caracterização de lactentes suplementados com DHA: a pesquisa clínica e suas dificuldades. 2024.