Title {1}	A randomized controlled double-blinded trial to assess the risk of gestational diabetes mellitus in iron-replete pregnant women who receive oral iron supplementation
Trial registration {2a and 2b}	CTRI/2024/04/065301 [registered on 05/04/2024]—trial registered prospectively
Protocol version {3}	Version 1.0.0
Funding {4}	The study is funded by the Indian Council of Medical Research (ICMR) under Investigator-Initiated Projects—Intermediate Grant with the ID: ICMR ref no. IIRPIG-2023-0000204
Author details {5a}	1. Joe Varghese, Department of Biochemistry, Christian Medical College, Vellore, Tamil Nadu, India 2. Molly Jacob, Department of Biochemistry, Christian Medical College, Vellore, Tamil Nadu, India 3. Padmanaban Venkatesan, Department of Biochemistry 4. Manisha Madhai Beck, Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India 5. Swati Rathore, Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India 6. Monica Peter, Department of Biochemistry, Christian Medical College, Vellore, Tamil Nadu, India 7. Anuja Abraham, Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India 8. Kavitha Abraham, Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India 9. Aaron Chapla, Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India 10. Prasanna Samuel, Department of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India
Name and contact information for the trial sponsor {5b}	This investigator-initiated study is funded by a grant award to Dr. Joe Varghese by the Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi, 110029, India Ph: 91-11-26588895/91-11-26588980, 91-11-26589794/91-11-26589336, 91-11-26588707 Fax: 91-11-26588662 Email: icmrhqds@sansad.nic.in
Role of sponsor {5c}	The ICMR, which is the funding agency for the study, has no role in study design, collection, management, analysis, and interpretation of data, and writing and submission of the report for publication. The funding agency will periodically monitor the progress and implementation of the study