The effect of vitamin B12-supplementation on actigraphy measured sleep pattern; a randomized control trial

Mari Hysing; Tor A Strand; Ram K Chandyo; Manjeswori Ulak; Suman Ranjitkar; Catherine Schwinger; Merina Shrestha; Ingrid Kvestad

doi:10.1016/j.clnu.2021.11.040

The effect of vitamin B12-supplementation on actigraphy measured sleep pattern; a randomized control trial

Clin Nutr. 2022 Feb;41(2):307-312. doi: 10.1016/j.clnu.2021.11.040. Epub 2021 Dec 6.

Authors

Mari Hysing¹, Tor A Strand², Ram K Chandyo³, Manjeswori Ulak⁴, Suman Ranjitkar⁵, Catherine Schwinger⁶, Merina Shrestha⁵, Ingrid Kvestad⁷

Affiliations

¹ Department of Psychosocial Science, Faculty of Psychology, University of Bergen, Norway. Electronic address: Mari.hysing@uib.no.
² Innlandet Hospital Trust, Department of Research, Norway and the Centre for International Health, University of Bergen, Norway; Center for Intervention Science in Maternal and Child Health, University of Bergen, Bergen, Norway.
³ Department of Community Medicine, Kathmandu Medical College, Sinamangal, Kathmandu, Nepal.
⁴ Center for Intervention Science in Maternal and Child Health, University of Bergen, Bergen, Norway; Department of Pediatrics, Child Health Research Project, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.
⁵ Department of Pediatrics, Child Health Research Project, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.
⁶ Center for Intervention Science in Maternal and Child Health, University of Bergen, Bergen, Norway.
⁷ Innlandet Hospital Trust, Department of Research, Norway and the Centre for International Health, University of Bergen, Norway; Regional Centre for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Centre, PO Box 22 Nygårdstangen, NO 5838, Bergen, Norway.

PMID: 34999324
DOI: 10.1016/j.clnu.2021.11.040

Abstract

Background: Vitamin B12 deficiency is common worldwide and has been associated with poor sleep. The effect of vitamin B12 supplementation on sleep in infants is not known.

Aims: To measure the effect of daily supplementation of vitamin B12 for one year on sleep in infants at risk of deficiency.

Methods: This was an individually randomized double-blind placebo-controlled trial in 600 infants in low-to middle-income neighborhoods in Bhaktapur, Nepal of daily supplementation of vitamin B12 for one year. Infants were included if they were 6-11 month year-old and with a length-for-age less than one z-score. Sleep was a predefined, secondary outcome, and was measured by actigraphy including sleep duration at night and total sleep duration (day and night), sleep onset latency (SOL), and wake after sleep onset (WASO). The effect of vitamin B12 on sleep was additionally assessed in predefined subgroups defined by stunting, underweight, vitamin B12 status, low birthweight, anemia and exclusive breastfeeding for 3 months.

Results: There was no effect of vitamin B12 supplementation on sleep duration at night, total sleep duration, or WASO. There was a small significant negative effect for SOL. None of the included subgroup analyses revealed effect modification on any of the sleep outcomes.

Conclusion: Overall, vitamin B12 supplementation did not have an effect on sleep in infants or for high-risk subgroups, with the exception of a small negative effect for SOL. The present study does not support vitamin B12 supplementation to improve sleep in infants.

Trial registration: clinicaltrials.gov: NCT02272842.

Universal trial number: U1111-1161-5187.

Keywords: B12 supplementation; Infant sleep; Randomized controlled trial; Sleep duration.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Actigraphy
Dietary Supplements*
Double-Blind Method
Humans
Infant
Male
Sleep / drug effects*
Sleep Wake Disorders / etiology
Sleep Wake Disorders / therapy*
Treatment Outcome
Vitamin B 12 / administration & dosage*
Vitamin B 12 Deficiency / complications
Vitamin B 12 Deficiency / physiopathology*

Substances

Vitamin B 12

Associated data

ClinicalTrials.gov/NCT02272842