Table 1 Summary of the trial according to the World Health Organization (WHO) trial registration minimal data set
| Â | Data | Information |
|---|---|---|
1 | Trial identification number (unique trial number) | ClinicalTrials.gov NCT03516734 |
2 | Trial registration date | 24 May 2018 |
3 | Secondary IDs | Bio# 17–177 (ERC, University of Saskatchewan) IRB#1139116–2 (IRB, Marywood University) BMRC/NREC/2016–2019/455 (Bangladesh Medical and Research Council) |
4 | Funding source(s) | Global Institute for Food Security, University of Saskatchewan, Canada; Nutrition International, Canada |
5 | Primary Sponsor | Albert Vandenberg, PhD (University of Saskatchewan) |
6 | Secondary Sponsor | Carol J Henry, PhD (University of Saskatchewan) |
7 | Responsible contact person (contact for public queries) | Carol J Henry, PhD, College of Pharmacy and Nutrition, University of Saskatchewan, 104 Clinic Place, Saskatoon, SK, S7N 2Z4, Saskatchewan, Canada. carol.henry@usask.ca |
8 | Research contact person (contact for scientific queries) | Diane M DellaValle, PhD, RDN, LDN, Nutrition, Athletic Training and Exercise Science, Department of Nutrition and Dietetics, Marywood University, 2300 Adams Avenue Scranton, PA 18509, USA. ddellavalle@marywood.edu |
9 | Title of the study (brief title) | Iron-fortified lentils to improve iron (Fe) status among adolescent girls in Bangladesh |
10 | Official scientific title of the study | Iron-fortified lentils to improve iron (Fe) status among adolescent girls in Bangladesh - study protocol for a double-blind randomized controlled trial. |
11 | Research ethics review and country of recruitment | • Ethical approved received from 1. University of Saskatchewan REB (Ref: Bio# 17–177) 2. Marywood University IRB (Ref: IRB#1139116–2) 3. Bangladesh Medical and Research Council. (Ref: BMRC/NREC/2016–2019/455) • Country of recruitment: Bangladesh |
12 | Health condition studied | Iron deficiency |
13 | Intervention | Fe-fortified lentils |
14 | Key inclusion and exclusion criteria | Inclusion criteria: adolescent girls aged 10–17 years, non-smoking, not pregnant, not breastfeeding, and generally healthy Exclusion criteria: adolescent girls with active illness during recruitment, or with known infectious disease |
15 | Study type | Double-blind, community-based, cluster-randomized controlled trial |
16 | Trial start date (anticipated) | Mid-September 2018 |
17 | Target sample size (total) | 1260 adolescent girls. |
18 | Recruitment status | Not yet recruiting |
19 | Primary outcome | Serum ferritin level and cognitive performance of the adolescent girls |
20 | Key secondary outcomes | 1. Growth (height, body weight, triceps skinfolds, mid-upper arm circumference) of non-pregnant adolescent girls in Bangladesh 2. Blood hemoglobin level of non-pregnant adolescent girls in Bangladesh |