Vitamin B12 Monotherapy Versus Combination Multi-Nutrient Therapy for Infantile Tremor Syndrome

A study assessed and compared the average Likert scores (representing caregiver assessments of change) and CAPUTE scores in children with Infantile Tremor Syndrome (ITS). 

This randomized, controlled, noninferiority trial examined two treatment approaches – daily injections of vitamin B12 alone versus daily injections of vitamin B12 combined with other multi-nutrients, one week and one month into the therapy.

Here, participants were children aged 3 months to 2 years diagnosed with Infantile Tremor Syndrome. The children were randomly assigned to receive either 1 mg of daily injectable vitamin B12 or 1 mg of daily injectable vitamin B12 in combination with other multi-nutrients (referred to as B12+MV). The primary outcome measure was the mean Likert score in both treatment groups at one week. Secondary outcome measures included the mean change in CAPUTE scores at one week of therapy and the mean change in CAPUTE and Vineland Social Maturity Scale (VSMS) scores after one month of treatment.

Of the 160 screened candidates, 72 (N=72) were enrolled and randomized. The mean (SD) Likert score in the B12 group (n=38) was 16.1 (3.7), while in the B12+MV group (n=34), it was 14.9 (3.7) – with the P value indicating no statistically significant difference. The mean (SD) change in CAPUTE (CAT/CLAMS) scores at one month did not show a statistically significant difference between the two groups. However, the mean (SD) change in the social quotient in the B12 monotherapy group, 35.0 (20.7), was significantly higher than in the B12+multinutrient group, 23.5 (15.4), with a p-value of 0.01.

Therefore, injectable vitamin B12 monotherapy for ITS led to an improvement that was at least as effective as combination multi-nutrient therapy. This finding strongly supports the role of vitamin B12 deficiency as the underlying cause of Infantile Tremor Syndrome.

Source: Kesavan S, Sankhyan N, Verma S, et al. Indian Journal of Pediatrics. 2022 Sep 1:1-6.