Standard

Ferritin-guided iron supplementation in whole blood donors : optimal dosage, donor response, return and efficacy (FORTE)-a randomised controlled trial protocol. / Karregat, Jan; Sweegers, Maike G.; Quee, Franke A. et al.

In: BMJ open, Vol. 12, No. 3, e056316, 09.03.2022, p. e056316.

Research output: Contribution to journalArticleAcademicpeer-review

Harvard

APA

Vancouver

Karregat J, Sweegers MG, Quee FA, Weekamp HH, Swinkels DW, Novotny VRMJ et al. Ferritin-guided iron supplementation in whole blood donors: optimal dosage, donor response, return and efficacy (FORTE)-a randomised controlled trial protocol. BMJ open. 2022 Mar 9;12(3):e056316. e056316. doi: 10.1136/bmjopen-2021-056316

Author

BibTeX

@article{8396bc7046ef4eb485aae54758860cc8,
title = "Ferritin-guided iron supplementation in whole blood donors: optimal dosage, donor response, return and efficacy (FORTE)-a randomised controlled trial protocol",
abstract = "BACKGROUND: Frequent whole blood donors have an increased risk of developing iron deficiency. Iron deficiency can have detrimental health effects when left untreated. Donation intervals are commonly too short to replenish iron stores and extending these reduces donor availability. Oral iron supplementation is known to shorten iron store recovery time but may also induce gastrointestinal complaints. We aim to optimise the effectiveness of iron supplements while minimising the risks of side effects. Therefore, we will evaluate the impact of different iron supplementation protocols in terms of dosage and frequency on ferritin and haemoglobin levels, gastrointestinal side effects, iron deficiency-related symptoms and donor return compared with placebo supplementation. METHODS: Twelve hundred whole blood donors with ferritin levels ≤30 µg/L are included into a double-blind, randomised controlled trial. Participants are randomly allocated to one of six arms, administering capsules containing 0 mg, 30 mg or 60 mg of iron, either on alternate days or daily for 56 days. At baseline and 56, 122 and 182 days of follow-up, ferritin and haemoglobin levels are measured, and compliance, donor return, dietary iron intake, gastrointestinal, iron deficiency-related symptoms and general health are assessed by questionnaire. ETHICS AND DISSEMINATION: This study will provide a comprehensive overview of the effects of different frequencies and dosages of administration of iron supplements on iron status and health effects, thereby considering individual differences in treatment adherence and lifestyle. The outcome will provide scientific evidence to guide the debate if and how oral iron supplements may support the recovery of whole blood donors with low ferritin levels. TRIAL REGISTRATION NUMBER: NL8590; The Dutch trial registry.",
keywords = "anaemia, blood bank & transfusion medicine, clinical trials",
author = "Jan Karregat and Sweegers, {Maike G.} and Quee, {Franke A.} and Weekamp, {Henri{\"e}tte H.} and Swinkels, {Dorine W.} and Novotny, {V. ra M. J.} and Zaaijer, {Hans L.} and {van den Hurk}, Katja",
note = "Funding Information: Funding Sanquin supported this research project: Product and Process Development Cellular Products Grant, project id: PPOC19-02/1-239. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2022",
month = mar,
day = "9",
doi = "10.1136/bmjopen-2021-056316",
language = "English",
volume = "12",
pages = "e056316",
journal = "BMJ open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "3",

}

RIS

TY - JOUR

T1 - Ferritin-guided iron supplementation in whole blood donors

T2 - optimal dosage, donor response, return and efficacy (FORTE)-a randomised controlled trial protocol

AU - Karregat, Jan

AU - Sweegers, Maike G.

AU - Quee, Franke A.

AU - Weekamp, Henriëtte H.

AU - Swinkels, Dorine W.

AU - Novotny, V. ra M. J.

AU - Zaaijer, Hans L.

AU - van den Hurk, Katja

N1 - Funding Information: Funding Sanquin supported this research project: Product and Process Development Cellular Products Grant, project id: PPOC19-02/1-239. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2022/3/9

Y1 - 2022/3/9

N2 - BACKGROUND: Frequent whole blood donors have an increased risk of developing iron deficiency. Iron deficiency can have detrimental health effects when left untreated. Donation intervals are commonly too short to replenish iron stores and extending these reduces donor availability. Oral iron supplementation is known to shorten iron store recovery time but may also induce gastrointestinal complaints. We aim to optimise the effectiveness of iron supplements while minimising the risks of side effects. Therefore, we will evaluate the impact of different iron supplementation protocols in terms of dosage and frequency on ferritin and haemoglobin levels, gastrointestinal side effects, iron deficiency-related symptoms and donor return compared with placebo supplementation. METHODS: Twelve hundred whole blood donors with ferritin levels ≤30 µg/L are included into a double-blind, randomised controlled trial. Participants are randomly allocated to one of six arms, administering capsules containing 0 mg, 30 mg or 60 mg of iron, either on alternate days or daily for 56 days. At baseline and 56, 122 and 182 days of follow-up, ferritin and haemoglobin levels are measured, and compliance, donor return, dietary iron intake, gastrointestinal, iron deficiency-related symptoms and general health are assessed by questionnaire. ETHICS AND DISSEMINATION: This study will provide a comprehensive overview of the effects of different frequencies and dosages of administration of iron supplements on iron status and health effects, thereby considering individual differences in treatment adherence and lifestyle. The outcome will provide scientific evidence to guide the debate if and how oral iron supplements may support the recovery of whole blood donors with low ferritin levels. TRIAL REGISTRATION NUMBER: NL8590; The Dutch trial registry.

AB - BACKGROUND: Frequent whole blood donors have an increased risk of developing iron deficiency. Iron deficiency can have detrimental health effects when left untreated. Donation intervals are commonly too short to replenish iron stores and extending these reduces donor availability. Oral iron supplementation is known to shorten iron store recovery time but may also induce gastrointestinal complaints. We aim to optimise the effectiveness of iron supplements while minimising the risks of side effects. Therefore, we will evaluate the impact of different iron supplementation protocols in terms of dosage and frequency on ferritin and haemoglobin levels, gastrointestinal side effects, iron deficiency-related symptoms and donor return compared with placebo supplementation. METHODS: Twelve hundred whole blood donors with ferritin levels ≤30 µg/L are included into a double-blind, randomised controlled trial. Participants are randomly allocated to one of six arms, administering capsules containing 0 mg, 30 mg or 60 mg of iron, either on alternate days or daily for 56 days. At baseline and 56, 122 and 182 days of follow-up, ferritin and haemoglobin levels are measured, and compliance, donor return, dietary iron intake, gastrointestinal, iron deficiency-related symptoms and general health are assessed by questionnaire. ETHICS AND DISSEMINATION: This study will provide a comprehensive overview of the effects of different frequencies and dosages of administration of iron supplements on iron status and health effects, thereby considering individual differences in treatment adherence and lifestyle. The outcome will provide scientific evidence to guide the debate if and how oral iron supplements may support the recovery of whole blood donors with low ferritin levels. TRIAL REGISTRATION NUMBER: NL8590; The Dutch trial registry.

KW - anaemia

KW - blood bank & transfusion medicine

KW - clinical trials

UR - http://www.scopus.com/inward/record.url?scp=85126167215&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2021-056316

DO - 10.1136/bmjopen-2021-056316

M3 - Article

C2 - 35264362

VL - 12

SP - e056316

JO - BMJ open

JF - BMJ open

SN - 2044-6055

IS - 3

M1 - e056316

ER -

ID: 22159549