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Does early vitamin B(12) supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania
INTRODUCTION: As many as 250 million children under the age of 5 may not be reaching their full developmental potential partly due to poor nutrition during pregnancy and the first 2 years of life. Micronutrients, including vitamin B(12), are important for the development of brain structure and funct...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5855385/ https://www.ncbi.nlm.nih.gov/pubmed/29472265 http://dx.doi.org/10.1136/bmjopen-2017-018962 |
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author | Winje, Brita Askeland Kvestad, Ingrid Krishnamachari, Srinivasan Manji, Karim Taneja, Sunita Bellinger, David C Bhandari, Nita Bisht, Shruti Darling, Anne Marie Duggan, Christopher P Fawzi, Wafaie Hysing, Mari Kumar, Tivendra Kurpad, Anura V Sudfeld, Christopher R Svensen, Erling Thomas, Susan Strand, Tor A |
author_facet | Winje, Brita Askeland Kvestad, Ingrid Krishnamachari, Srinivasan Manji, Karim Taneja, Sunita Bellinger, David C Bhandari, Nita Bisht, Shruti Darling, Anne Marie Duggan, Christopher P Fawzi, Wafaie Hysing, Mari Kumar, Tivendra Kurpad, Anura V Sudfeld, Christopher R Svensen, Erling Thomas, Susan Strand, Tor A |
author_sort | Winje, Brita Askeland |
collection | PubMed |
description | INTRODUCTION: As many as 250 million children under the age of 5 may not be reaching their full developmental potential partly due to poor nutrition during pregnancy and the first 2 years of life. Micronutrients, including vitamin B(12), are important for the development of brain structure and function; however, the timing, duration and severity of deficiencies may alter the impact on functional development outcomes. Consequently, to fully explore the effect of vitamin B(12) on cognitive function, it is crucial to measure neurodevelopment at different ages, in different populations and with vitamin B(12) supplementation at different times during the critical periods of neurodevelopment. METHODS AND ANALYSIS: In this project, we follow up children from four recently completed randomised placebo-controlled trials of oral vitamin B(12) supplementation, two in India and two in Tanzania, to explore the long-term effects on neurodevelopmental outcomes and growth. All the included trials provided at least two recommended dietary allowances of oral vitamin B(12) daily for at least 6 months. Vitamin B(12) was supplemented either during pregnancy, early infancy or early childhood. Primary outcomes are neurodevelopmental status, cognitive function and growth later in childhood. We apply validated and culturally appropriate instruments to identify relevant developmental outcomes. All statistical analyses will be done according to intention-to-treat principles. The project provides an excellent opportunity to examine the effect of vitamin B(12) supplementation in different periods during early life and measure the outcomes later in childhood. ETHICS AND DISSEMINATION: The study has received ethical approvals from all relevant authorities in Norway, USA, Tanzania and India and complies fully with ethical principles for medical research. Results will be presented at national and international research and policy meetings and published in peer-reviewed scientific journals, preferably open access. TRIAL REGISTRATION NUMBER: NCT00641862 (Bangalore); NCT00717730, updated CTRI/2016/11/007494 (Delhi); NCT00197548 and NCT00421668 (Dar es Salaam). |
format | Online Article Text |
id | pubmed-5855385 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-58553852018-03-19 Does early vitamin B(12) supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania Winje, Brita Askeland Kvestad, Ingrid Krishnamachari, Srinivasan Manji, Karim Taneja, Sunita Bellinger, David C Bhandari, Nita Bisht, Shruti Darling, Anne Marie Duggan, Christopher P Fawzi, Wafaie Hysing, Mari Kumar, Tivendra Kurpad, Anura V Sudfeld, Christopher R Svensen, Erling Thomas, Susan Strand, Tor A BMJ Open Nutrition and Metabolism INTRODUCTION: As many as 250 million children under the age of 5 may not be reaching their full developmental potential partly due to poor nutrition during pregnancy and the first 2 years of life. Micronutrients, including vitamin B(12), are important for the development of brain structure and function; however, the timing, duration and severity of deficiencies may alter the impact on functional development outcomes. Consequently, to fully explore the effect of vitamin B(12) on cognitive function, it is crucial to measure neurodevelopment at different ages, in different populations and with vitamin B(12) supplementation at different times during the critical periods of neurodevelopment. METHODS AND ANALYSIS: In this project, we follow up children from four recently completed randomised placebo-controlled trials of oral vitamin B(12) supplementation, two in India and two in Tanzania, to explore the long-term effects on neurodevelopmental outcomes and growth. All the included trials provided at least two recommended dietary allowances of oral vitamin B(12) daily for at least 6 months. Vitamin B(12) was supplemented either during pregnancy, early infancy or early childhood. Primary outcomes are neurodevelopmental status, cognitive function and growth later in childhood. We apply validated and culturally appropriate instruments to identify relevant developmental outcomes. All statistical analyses will be done according to intention-to-treat principles. The project provides an excellent opportunity to examine the effect of vitamin B(12) supplementation in different periods during early life and measure the outcomes later in childhood. ETHICS AND DISSEMINATION: The study has received ethical approvals from all relevant authorities in Norway, USA, Tanzania and India and complies fully with ethical principles for medical research. Results will be presented at national and international research and policy meetings and published in peer-reviewed scientific journals, preferably open access. TRIAL REGISTRATION NUMBER: NCT00641862 (Bangalore); NCT00717730, updated CTRI/2016/11/007494 (Delhi); NCT00197548 and NCT00421668 (Dar es Salaam). BMJ Publishing Group 2018-02-22 /pmc/articles/PMC5855385/ /pubmed/29472265 http://dx.doi.org/10.1136/bmjopen-2017-018962 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Nutrition and Metabolism Winje, Brita Askeland Kvestad, Ingrid Krishnamachari, Srinivasan Manji, Karim Taneja, Sunita Bellinger, David C Bhandari, Nita Bisht, Shruti Darling, Anne Marie Duggan, Christopher P Fawzi, Wafaie Hysing, Mari Kumar, Tivendra Kurpad, Anura V Sudfeld, Christopher R Svensen, Erling Thomas, Susan Strand, Tor A Does early vitamin B(12) supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania |
title | Does early vitamin B(12) supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania |
title_full | Does early vitamin B(12) supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania |
title_fullStr | Does early vitamin B(12) supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania |
title_full_unstemmed | Does early vitamin B(12) supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania |
title_short | Does early vitamin B(12) supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania |
title_sort | does early vitamin b(12) supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in india and tanzania |
topic | Nutrition and Metabolism |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5855385/ https://www.ncbi.nlm.nih.gov/pubmed/29472265 http://dx.doi.org/10.1136/bmjopen-2017-018962 |
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