Apte Aditi, Kapoor Mudra, Naik Sadanand, Lubree Himangi, Khamkar Pooja, Singh Diksha, Agarwal Dhiraj, Roy Sudipto, Kawade Anand, Juvekar Sanjay, Banerjee Rinti, Bavdekar Ashish
Department of Biosciences and Bioengineering, Nanomedicine Laboratory, Indian Institute of Technology Bombay, Powai, Mumbai, India.
PRERNA Young Scientist, KEM Hospital Research Centre, Pune, India.
BMC Nutr. 2021 Sep 8;7(1):48. doi: 10.1186/s40795-021-00458-8.
Micronutrient deficiency is a known cause of adverse neurodevelopment and growth. Poor adherence to oral regimes of micronutrient supplements is a known challenge during the implementation of supplementation programs. The present study evaluates the benefits of liposomal encapsulated micronutrient fortified body oils (LMF oil) that can be used for infant body massage in terms of neurodevelopment and prevention of deficiency.
Double-blind randomized clinical trial.
A total of 444 healthy infants aged 4-7 weeks were randomized to receive either LMF oil (containing iron, vitamin D, folate, and vitamin B12) or placebo oil for gentle body massage till 12 months of age. Blood samples were collected at 6 and 12 months for transferrin saturation (TSAT), hemoglobin, and 25-hydroxy vitamin (25-OH-D) levels. Mental and motor development was assessed at 12 months using developmental assessment for Indian Infants (DASII).
A total of 391 infants completed the study. There was no significant improvement in the hemoglobin in the intervention group at 12 months of age as compared to the placebo group [- 0.50 vs.-0.54 g%]. There was a marginally significant improvement in 25-OH-D at 12 months in the LMF oil group [+ 1.46vs.-0.18 ng/ml, p = 0.049]. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age [adjusted mean change + 0.11vs.-0.51 g%, p = 0.043]. The mental or motor developmental quotients in the intervention group were not significantly different from those in the placebo group.
Use of LMF oil for prevention of nutritional deficiency did not offer significant protection against nutritional anemia but prevented vitamin D deficiency to some extent with improvement in 25-OH-D at 12 months. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age. The intervention did not result in significant improvement in mental or motor development. Further evaluation with increased doses needs to be undertaken.
CTRI no: CTRI/2017/11/010710 ; dated 30/11/2017.
微量营养素缺乏是不良神经发育和生长的已知原因。在实施补充计划期间，口服微量营养素补充剂的依从性差是一个已知的挑战。本研究评估了可用于婴儿身体按摩的脂质体包裹微量营养素强化身体油（LMF油）在神经发育和预防缺乏方面的益处。
双盲随机临床试验。
总共444名4至7周龄的健康婴儿被随机分配接受LMF油（含铁、维生素D、叶酸和维生素B12）或安慰剂油进行轻柔的身体按摩，直至12个月龄。在6个月和12个月时采集血样，检测转铁蛋白饱和度（TSAT）、血红蛋白和25-羟基维生素（25-OH-D）水平。在12个月时使用印度婴儿发育评估（DASII）评估智力和运动发育。
共有391名婴儿完成了研究。与安慰剂组相比，干预组在12个月龄时血红蛋白没有显著改善[-0.50 vs.-0.54 g%]。LMF油组在12个月时25-OH-D有轻微显著改善[+1.46 vs.-0.18 ng/ml，p = 0.049]。在中度贫血婴儿亚组中，干预预防了12个月龄时血红蛋白的下降[调整后平均变化+0.11 vs.-0.51 g%，p = 0.043]。干预组的智力或运动发育商与安慰剂组没有显著差异。
使用LMF油预防营养缺乏对营养性贫血没有显著保护作用，但在一定程度上预防了维生素D缺乏，12个月时25-OH-D有所改善。在中度贫血婴儿亚组中，干预预防了12个月龄时血红蛋白的下降。该干预并未导致智力或运动发育的显著改善。需要进行更高剂量的进一步评估。
CTRI编号：CTRI/2017/11/010710；日期为2017年11月30日。
