Effect of Parental Peri-conceptional Vitamin B12 Supplementation on Infant Neurocognitive Development in Offspring

NCT03088189 | Terminated DMC

• 1 other identifier: KEMHRC/ADHOC/25
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal nutrition is an important factor which determines fetal growth and development. Micronutrients vitamin B12 and folic acid are essential determinants of one carbon metabolism and play an important role in DNA synthesis, methylation and epigenetic regulation of gene expression. Diabetes unit of KEMHRC, Pune has been conducting the Pune Rural Intervention in Young Adolescents since last 3 years. Subjects of the PMNS cohort have been randomized as part of a controlled trial of nutritional intervention with vitamin B12 vs multiple micronutrient and milk protein vs placebo. This study aims to understand the intergenerational effects of vitamin B12 supplementation. 74 infants have been born in this trial since 2013. This study would assess neurocognitive development of offspring born to mothers who are part of the nutritional intervention trial; on the Bayley scales of infant and toddler development - III. The study aims to test the hypothesis that infants born to mothers who received vitamin B12 would have favorable infant neurocognitive development scores as compared to placebo. And this effect would be enhanced in the group whose mothers received MMN with milk protein.

Conditions

Neurodevelopmental Disorders

Keywords

maternal nutrition; periconceptional; neurocognitive development

Outcome Measures

Primary Outcomes (1)

• Composite cognitive score and subdomain scores on Bayley scales of infant and toddler development - III

  Scores obtained on the assessment scale would be compared between groups

  assessed at 2 years of age

Secondary Outcomes (1)

• Total score on Child Behavior Check list

  assessed at 2 years of age

Study Arms (3)

Vitamin B12 group

Mothers in the group are receiving vitamin B12 2µg supplements daily

Multiple micronutrient group

mothers in this group are receiving vitamin B12 2µg plus multiple micronutrients (MMN) plus 20g of milk powder

Placebo

Mothers are receiving placebo

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

children born to mothers who are part of an ongoing nutritional intervention trial. Mothers are randomised to receive either Vitamin B12, B12 with multiple micronutrients and milk protein or placebo

You may qualify if:

• Infants born to parent enrolled in the PRIYA trial
• Age \> 24 months and \< 48 months
• Informed consent obtained from parents

You may not qualify if:

• Infants diagnosed to have known genetic syndromes with mental retardation or cerebral palsy
• Infants with recent immunization or febrile illness will be assessed 1 week after resolution

Sponsors & Collaborators

• Kem Hospital, Pune, India: lead

Study Sites (1)

Diabetes Unit, Kem Hospital Research Centre

Pune, Maharashtra, 411014, India

Location

Related Links

• Official webpage of diabetes unit KEM hospital research center Pune

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Chittaranjan Yajnik, MD

  KEM Hospital research center, Pune

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Diabetes Unit

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 23, 2017
• Study Start: May 9, 2017
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)