Study concept and design: West, Shamim, Labrique, Klemm, Christian.
Acquisition, analysis, or interpretation of data: West, Shamim, Mehra, Labrique, Ali, Shaikh, Klemm, Wu, Mitra, Haque, Hanif, Massie, Merrill, Schulze, Christian.
Drafting of the manuscript: West, Christian.
Critical revision of the manuscript for important intellectual content: West, Shamim, Mehra, Labrique, Ali, Shaikh, Klemm, Wu, Mitra, Haque, Hanif, Massie, Merrill, Schulze, Christian.
Statistical analysis: Wu, Christian.
Obtained funding: West.
Administrative, technical, or material support: Mehra, Shamim, Ali, Shaikh, Mitra, Haque, Hanif, Merrill.
Study supervision: West, Shamim, Mehra, Labrique, Ali, Shaikh, Klemm, Merrill, Christian.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr West reported a grant from DSM awarded to the Program in Human Nutrition at Johns Hopkins Bloomberg School of Public Health and having given 2 scientific presentations in 2 consecutive years at DSM in Basel, Switzerland, with accommodations provided. Dr Christian reported giving a presentation at DSM in Basel with accommodations provided. No other disclosures were reported.
Funding/Support: The JiVitA-3 Trial was funded through grant OPP614 (Global Control of Micronutrient Deficiency) from the Bill and Melinda Gates Foundation (Ellen Piwoz, ScD, Senior Program Officer). Additional assistance was received from the Sight and Life Global Nutrition Research Institute. DSM formulated, prepared, and delivered in-country micronutrient premixes for supplement production gratis and tested supplement potency throughout the trial gratis. Beximco Pharmaceuticals produced, bottled, labeled, and delivered to the field site 16 million study tablets during the trial gratis and delivered an additional 1 million multiple micronutrient supplements gratis to support posttrial antenatal supplement delivery services in the community.
Role of the Funder/Sponsor: The Bill and Melinda Gates Foundation, DSM, Sight and Life, and Beximco Pharmaceuticals had no role in the design of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: Oversight with respect to data and safety monitoring was provided by an international board: Nancy Sloan, DrPH, Columbia University, United States (chair); James Tonascia, PhD, Johns Hopkins University, United States; Anthony de Costello, FRCP, University College London, United Kingdom; Shamsun Nahar, PhD, King Khalid University, Saudi Arabia; Md. Khalequzaman, Bangladesh; and Tahmeed Ahmed, PhD, International Centre for Diarrheal Disease Research, Bangladesh. Joanne Katz, ScD, Johns Hopkins University, assisted in analyses for data and safety monitoring board reports. Alfred Sommer, MD, Johns Hopkins University, and Mahbubur Rashid, PhD, Partners in Population and Development, provided technical guidance. Field management was overseen by Azaduzzaman. Rhonda Skinner, Johns Hopkins University, assisted with the formatting of the manuscript. No one received compensation besides salary.