Evidence map›Paper›PMID 36048348›Full record

Trial reportIndian journal of pediatrics2023

A Randomized, Controlled, Noninferiority Trial Comparing Vitamin B12 Monotherapy Versus Combination Multinutrient Therapy with Vitamin B12 for Efficacy in Treatment of Infantile Tremor Syndrome.

Shivan Kesavan, Naveen Sankhyan, Savita Verma, Prateek Bhatia, Prahbhjot Malhi, Lokesh Saini, Arushi Gahlot Saini, Renu Suthar, Jitendra Kumar Sahu

Abstract readRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in Indian journal of pediatrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 34% 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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Shivan KesavanPediatric Neurology Unit, Department of Pediatrics, Advanced Pediatrics Center, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.
Naveen SankhyanPediatric Neurology Unit, Department of Pediatrics, Advanced Pediatrics Center, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India. drnsankhyan@yahoo.co.in.ORCID 0000-0003-4929-1163
Savita VermaPediatric Biochemistry, Department of Pediatrics, Advanced Pediatrics Center, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Prateek BhatiaPediatric Hematology, Department of Pediatrics, Advanced Pediatrics Center, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Prahbhjot MalhiChild Psychology Unit, Department of Pediatrics, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Lokesh SainiPediatric Neurology Unit, Department of Pediatrics, Advanced Pediatrics Center, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.
Arushi Gahlot SainiPediatric Neurology Unit, Department of Pediatrics, Advanced Pediatrics Center, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.
Renu SutharPediatric Neurology Unit, Department of Pediatrics, Advanced Pediatrics Center, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.
Jitendra Kumar SahuPediatric Neurology Unit, Department of Pediatrics, Advanced Pediatrics Center, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.
Post Graduate Institute of Medical Education and Research · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo compare the mean Likert (caregiver impression of change) and CAPUTE scores in children with ITS treated with daily injectable vitamin B12 alone versus injectable vitamin B12 with other multinutrients at 1 wk and 1 mo of therapy.

methodsThis was an open-label, active-controlled, assessor-blinded, noninferiority, randomized clinical trial. The participants included children aged 3 mo to 2 y with infantile tremor syndrome. Children were randomized to receive either 1 mg of daily injectable vitamin B12 or 1 mg of daily injectable vitamin B12 with other multinutrients (B12 + MV). Primary outcome measure was the mean Likert score in the two arms at 1 wk. Secondary outcome measures were mean change in CAPUTE scores at 1 wk of therapy; and mean change in CAPUTE and Vineland Social Maturity Scale (VSMS) scores after 1 mo of treatment.

resultsSeventy-two (N = 72) of the 160 screened were enrolled and randomized. The mean (SD) Likert score in the B12 group (n = 38) was 16.1 (3.7) and in the B12 + MV group (n = 34) was 14.9 (3.7); p = 0.237. Mean (SD) change in CAPUTE (CAT/CLAMS) at 1 mo in the groups was not statistically different. The mean (SD) change in social quotient in the B12 monotherapy group, 35.0 (20.7) was significantly higher than the B12 + multinutrient group 23.5 (15.4); p=0.01.

conclusionInjectable vitamin B12 monotherapy in ITS resulted in an improvement that was noninferior to combination multinutrient therapy, strongly supporting vitamin B12 deficiency as the cause of infantile tremor syndrome.

trial registrationThe trial was registered at CTRI.org (CTRI/2018/05/013841).

Indexed as

Vitamin B 12Vitamin B 12 DeficiencyCombined Modality TherapyDietary SupplementsHumansSyndromeTremorVitaminsVitamin B 12VitaminsCobalaminMovement disorderNeuroregressionTropical

Identifiers

PMID36048348
OpenAlexW4294031677

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.