Evidence map›Paper›PMID 34493339›Full record

ArticleBMC nutrition2021

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.

Aditi Apte, Mudra Kapoor, Sadanand Naik, Himangi Lubree, Pooja Khamkar, Diksha Singh, Dhiraj Agarwal, Sudipto Roy, Anand Kawade, Sanjay Juvekar and 2 more

Open access · goldAbstract read
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Article in BMC nutrition, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 43% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Aditi ApteDepartment of Biosciences and Bioengineering, Nanomedicine Laboratory, Indian Institute of Technology Bombay, Powai, Mumbai, India. aditi.apte@kemhrcvadu.org.
Mudra KapoorDepartment of Biosciences and Bioengineering, Nanomedicine Laboratory, Indian Institute of Technology Bombay, Powai, Mumbai, India.
Sadanand NaikKEM Hospital, Pune, India.
Himangi LubreeVadu Rural Health Program, KEM Hospital Research Centre, Pune, India.
Pooja KhamkarVadu Rural Health Program, KEM Hospital Research Centre, Pune, India.
Diksha SinghVadu Rural Health Program, KEM Hospital Research Centre, Pune, India.
Dhiraj AgarwalVadu Rural Health Program, KEM Hospital Research Centre, Pune, India.
Sudipto RoyPRERNA Young Scientist, KEM Hospital Research Centre, Pune, India.
Anand KawadeVadu Rural Health Program, KEM Hospital Research Centre, Pune, India.
Sanjay JuvekarVadu Rural Health Program, KEM Hospital Research Centre, Pune, India.
Rinti BanerjeeDepartment of Biosciences and Bioengineering, Nanomedicine Laboratory, Indian Institute of Technology Bombay, Powai, Mumbai, India.
Ashish BavdekarVadu Rural Health Program, KEM Hospital Research Centre, Pune, India.
Dr. D. Y. Patil Medical College, Hospital and Research Centre · INIndian Institute of Technology Bombay · INCollege of Medicine & JNM Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMicronutrient 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

designDouble-blind randomized clinical trial.

methodsA 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).

resultsA 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.

conclusionUse 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 registrationCTRI no: CTRI/2017/11/010710 ; dated 30/11/2017.

Indexed as

AnemiaBody massageFortificationIronVitamin D

Identifiers

PMID34493339
PMCPMC8524365
OpenAlexW3195299134

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.