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

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ClinicalTrials.gov Identifier: NCT03088189
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Chittaranjan S Yajnik, Kem Hospital, Pune, India

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.

Condition or disease
Neurodevelopmental Disorders

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Parental Peri-conceptional Vitamin B12 Supplementation on Infant Neurocognitive Development in Offspring
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Group/Cohort
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



Primary Outcome Measures :
  1. Composite cognitive score and subdomain scores on Bayley scales of infant and toddler development - III [ Time Frame: assessed at 2 years of age ]
    Scores obtained on the assessment scale would be compared between groups


Secondary Outcome Measures :
  1. Total score on Child Behavior Check list [ Time Frame: assessed at 2 years of age ]
    Scores obtained on the assessment scale would be compared between groups



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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  1. Infants born to parent enrolled in the PRIYA trial
  2. Age > 24 months and < 48 months
  3. Informed consent obtained from parents

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088189


Contacts
Contact: chittaranjan Yajnik, MD 00-91-20-26061958 diabetes@kemdiabetes.org
Contact: rishikesh v behere, MD 00-91-20-26061958 rvbehere@gmail.com

Locations
India
Diabetes Unit, Kem Hospital Research Centre Recruiting
Pune, Maharashtra, India, 411014
Contact: Chittaranjan S Yajnik, MD         
Principal Investigator: Chittaranjan S Yajnik, MD , FRCP         
Sponsors and Collaborators
Kem Hospital, Pune, India
Investigators
Principal Investigator: Chittaranjan Yajnik, MD KEM Hospital research center, Pune

Additional Information:
Responsible Party: Dr. Chittaranjan S Yajnik, Director, Diabetes Unit, Kem Hospital, Pune, India
ClinicalTrials.gov Identifier: NCT03088189     History of Changes
Other Study ID Numbers: KEMHRC/ADHOC/25
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Chittaranjan S Yajnik, Kem Hospital, Pune, India:
maternal nutrition
periconceptional
neurocognitive development

Additional relevant MeSH terms:
Neurodevelopmental Disorders
Mental Disorders
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics