TY - JOUR
T1 - Efficacy of Zinc Fortified and Fermented Wheat Flour (EZAFFAW)
T2 - A randomized controlled trial protocol
AU - Das, Jai K.
AU - Padhani, Zahra Ali
AU - Khan, Muhammad
AU - Mirani, Mushtaq
AU - Rizvi, Arjumand
AU - Chauhadry, Imran Ahmed
AU - Yasin, Rahima
AU - Ismail, Tariq
AU - Akhtar, Saeed
AU - Begum, Kehkashan
AU - Iqbal, Junaid
AU - Humayun, Khadija
AU - Naseem, Hamna Amir
AU - Malik, Kauser Abdulla
AU - Bhutta, Zulfiqar A.
N1 - Publisher Copyright:
© 2024 Das et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2024/6
Y1 - 2024/6
N2 - Background Zinc deficiency poses significant health risks, particularly in low-income settings. This study aims to evaluate the impact of agronomically zinc biofortified (fermented and non-fermented) and post-harvest wheat flour flatbread on zinc status and metabolic health in adolescents and adult women in rural Pakistan. Methods A four-arm triple-blind randomized controlled trial will be conducted in a rural district of Pakistan. Participants (adolescents aged 10–19 and adult women aged 20–40) will be assigned to receive fermented or unfermented high zinc agronomically biofortified wheat flour flatbread, post-harvest zinc-fortified wheat flour flatbread, or low zinc conventional whole wheat flour flatbread. The meal would be served once a day, six days a week for six months. The study aims to enroll 1000 participants and will be analyzed based on the intention-to-treat principle. The trial is registered with number NCT06092515. Outcomes Primary outcomes will include serum zinc concentration and metabolic markers, while secondary outcomes include anthropometric measurements, blood pressure, and dietary intake. Conclusion This trial will provide valuable insights into the efficacy of agronomically zinc biofortified wheat flour in improving zinc status and metabolic health. Findings may inform public health strategies to combat zinc deficiency in resource-limited settings.
AB - Background Zinc deficiency poses significant health risks, particularly in low-income settings. This study aims to evaluate the impact of agronomically zinc biofortified (fermented and non-fermented) and post-harvest wheat flour flatbread on zinc status and metabolic health in adolescents and adult women in rural Pakistan. Methods A four-arm triple-blind randomized controlled trial will be conducted in a rural district of Pakistan. Participants (adolescents aged 10–19 and adult women aged 20–40) will be assigned to receive fermented or unfermented high zinc agronomically biofortified wheat flour flatbread, post-harvest zinc-fortified wheat flour flatbread, or low zinc conventional whole wheat flour flatbread. The meal would be served once a day, six days a week for six months. The study aims to enroll 1000 participants and will be analyzed based on the intention-to-treat principle. The trial is registered with number NCT06092515. Outcomes Primary outcomes will include serum zinc concentration and metabolic markers, while secondary outcomes include anthropometric measurements, blood pressure, and dietary intake. Conclusion This trial will provide valuable insights into the efficacy of agronomically zinc biofortified wheat flour in improving zinc status and metabolic health. Findings may inform public health strategies to combat zinc deficiency in resource-limited settings.
UR - http://www.scopus.com/inward/record.url?scp=85196547121&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0304462
DO - 10.1371/journal.pone.0304462
M3 - Article
AN - SCOPUS:85196547121
SN - 1932-6203
VL - 19
JO - PLoS ONE
JF - PLoS ONE
IS - 6
M1 - e0304462
ER -
