Abstract summary 

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, 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 on cognitive function, it is crucial to measure neurodevelopment at different ages, in different populations and with vitamin B supplementation at different times during the critical periods of neurodevelopment.In this project, we follow up children from four recently completed randomised placebo-controlled trials of oral vitamin B 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 daily for at least 6 months. Vitamin B 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 supplementation in different periods during early life and measure the outcomes later in childhood.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.NCT00641862 (Bangalore); NCT00717730, updated CTRI/2016/11/007494 (Delhi); NCT00197548 and NCT00421668 (Dar es Salaam).

Authors & Co-authors:  Winje Brita Askeland BA Kvestad Ingrid I Krishnamachari Srinivasan S Manji Karim K Taneja Sunita S Bellinger David C DC Bhandari Nita N Bisht Shruti S Darling Anne Marie AM Duggan Christopher P CP Fawzi Wafaie W Hysing Mari M Kumar Tivendra T Kurpad Anura V AV Sudfeld Christopher R CR Svensen Erling E Thomas Susan S Strand Tor A TA

Study Outcome 

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