Adults 6 Months to 11 Months, any sex, with Development or Vitamin Deficiency. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Bayley Scales of Infant Development Version 3Primary· 12 months
Cognitive, Fine Motor, Gross Motor, Receptive language, and Expressive language scaled scores of the Bayley Scales of Infant Development version 3. This scale measures different aspects of neurodevelopment. The mean (SD) scores are usually 100 (15), and 95% of the population has scores between 70 and 130 (theoretical max/means 0/200). The higher scores, the better neurodevelopment; the scale is normalized on age.
Cognitive
Group
Value
95% CI
Vitamin B12
8.1
± 1.6
Placebo
8.2
± 1.5
Receptive language
Group
Value
95% CI
Vitamin B12
9.0
± 2.3
Placebo
8.9
± 2.5
Expressive language
Group
Value
95% CI
Vitamin B12
8.6
± 2.6
Placebo
8.5
± 2.4
Fine Motor
Group
Value
95% CI
Vitamin B12
10.7
± 1.6
Placebo
10.9
± 1.8
Gross Motor
Group
Value
95% CI
Vitamin B12
9.2
± 2.0
Placebo
9.1
± 1.7
Hemoglobin ConcentrationPrimary· 12 months
Change in hemoglobin concentration from baseline to end study.
Group
Value
95% CI
Vitamin B12
1.1
± 1.1
Placebo
1.0
± 1.2
The Effect of Vitamin B12 Supplementation on Markers of Vitamin B StatusSecondary· 12 months
We will draw a blood sample at study start and at end study to measure to what extent vitamin status is altered.
Cobalamin
Group
Value
95% CI
Vitamin B12
316.3
± 1.7
Placebo
290.1
± 1.6
homocysteine'
Group
Value
95% CI
Vitamin B12
6.6
± 1.3
Placebo
8.2
± 1.4
Methyl Malonic acid
Group
Value
95% CI
Vitamin B12
0.3
± 1.9
Placebo
.4
± 2.1
Immediate Adverse Effects of the InterventionSecondary· 12 months
We will investigate side effects such as pain, nausea, vomiting, regurgitation, allergic reactions and others after each dose of the intervention.
Group
Value
95% CI
Vitamin B12
3
Placebo
0
Vitamin B12
8
Placebo
10
Vitamin B12
7
Placebo
2
Vitamin B12
1
Placebo
1
Extended Followup: Neurodevelopment (IQ)Secondary· 3 years
Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition. This is a test of general abilities ("IQ-test") Expected mean (SD): 100 (15), higher value indicate better cognitive functioning. Range approx. 40-140
Group
Value
95% CI
Vitamin B12
84.4
± 8.4
Placebo
85.0
± 8.6
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of Vitamin B12 is animal-source foods. Vitamin B12 is crucial for normal cell division and is necessary for brain growth as well as for the maintenance of its normal function. Deficiency is also associated with impaired growth. In a previous study, we demonstrated that vitamin B12 administration over a period of six months enhanced growth, and scores on a neuro-developmental test in young Indian children. However, the overall effect was small and, for the developmental scores significant only in those that were malnourished at the start of the study.
Our findings need to be verified in trials targeting younger, malnourished children and with longer supplementation time.
Hypothesis: This proposed study will test three hypotheses; to measure to what extent 2 recommended daily allowances (RDA) of vitamin B12 administration for one year to stunted children improves; 1) growth, 2) neurodevelopment, and 3) hemoglobin concentration.
Study design: Randomized placebo-controlled trial. Half of the children will receive a paste containing vitamin B12, the other half the same paste but without vitamin B12.
Study participants and site: 600 malnourished infants in Bhaktapur municipality in Nepal. In this population we have demonstrated that vitamin B12 deficiency and poor growth is common in early childhood.
Intervention: Daily administration of a paste containing vitamin B12 or placebo for 12 months
Data: The main outcomes of this study are scores on developmental assessments tools and growth measured every month for 12 months.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre For International Health
Last refreshed: 18 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02272842.