Title: Efficacy of transdermal delivery of liposomal micronutrients through body oil massage on neurodevelopmental and micronutrient deficiency status in infants: Results of a randomized placebo controlled clinical trial 

Abstract

Background: 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. Study design: Double-blind randomized clinical trial Methods: 444 healthy infants aged 4-7weeks were randomized to receive either LMF oil (containing iron, vitamin D, folate, and vitamin B12) or placebo oil for gentle body massage till 12months 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). Results: 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 gm%]. There was a marginally significant improvement in 25-OH-D at 12 months in the LMF oil group [+1.46vs.-0.18ng/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.-0.51gm%, p=0.043]. The mental or motor developmental quotients in the intervention group were not significantly different from those in the placebo group. Conclusion: 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.Trial registration: CTRI no: CTRI/2017/11/010710; dated 30/11/2017 [http://ctri.nic.in/Clinicaltrials/advancesearchmain.php ]