Project Title: Optimizing Material Nutrition

Project Description: The project long tittle is Optimizing Maternal Nutrition: Adoptive trials and Molecular methods to Improve Maternal and Child and Newborn Health — MM4NM. It will be conducted at the IHI's Kingani Clinical Trials Facility in Bagamoyo. The performance period of this study is 16 months. Part 1 (Apr-Jun 2021) was a preparatory phase, Part 2 (Jul 2021 — 31 July 2022) is the implementation phase. The study is a single parallel, single arm, open label,... The project long tittle is Optimizing Maternal Nutrition: Adoptive trials and Molecular methods to Improve Maternal and Child and Newborn Health — MM4NM. It will be conducted at the IHI's Kingani Clinical Trials Facility in Bagamoyo. The performance period of this study is 16 months. Part 1 (Apr-Jun 2021) was a preparatory phase, Part 2 (Jul 2021 — 31 July 2022) is the implementation phase. The study is a single parallel, single arm, open label, Phase I dose escalation trial of vitamin B12 supplementation in late pregnancy (00 30 weeks gestation). The study will also include a non-pregnant arm. There will be a minimum of 5 women per dose, thus the study estimates a maximum sample size of 50 women. The primary outcome of the Phase I trial will be serum vitamin B12 and holotranscobalamin. Study nurses will primarily be responsible for data collection including baseline social and demographic data, clinical history, assessment of pregnant morbidities, dietary intake assessment, and collecting blood and urine specimens. Furthermore, to ensure data safety of trial participants we will establish an independent Data Safety Monitoring Board (DSMB) which will establish a plan for an interim data looks, and we will provide close and open reports to the DSMB at intervals. The results of the trial will be disseminated to the participants and the key stakeholders. Read more

Principal Investigator : Honorati Masanja

Department Name :

Time frame: (2021-04-01) - (2024-03-31)

Funding Partners
Bill and Melinda Gates Foundation (BMGF) (Prime)
Tanzania Training Center for International Health (Normal)
The University of Birmingham (Normal)
External Collaborating Partners
None added yet.