Iron supplementation in patients with anemia

ISRCTN	ISRCTN96148278
DOI	https://doi.org/10.1186/ISRCTN96148278
Secondary identifying numbers	0719010092

Submission date: 20/06/2022
Registration date: 25/10/2022
Last edited: 20/04/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Anemia is a condition in which there are not enough healthy red blood cells to carry adequate oxygen to the body's tissues. It is treated with iron supplementation. Up to now, the blanket distribution of iron supplementation in Indonesia to reproductive-age women has continued with unsatisfactory results. The aim of the study is to evaluate the effectiveness of iron supplementation to increase hemoglobin levels.

Who can participate?
Patients aged between 15–49 years with moderate or severe anemia

What does the study involve?
Participants are randomly allocated to take iron tablets with folic acid or iron tablets with multivitamins for 30 days. Hemoglobin levels are measured at the start of the study and after 30 days

What are the possible benefits and risks of participating?
Participants may benefit from a free medical check related to their anemia and treatment with iron supplementation. There is a risk of side effects from iron supplementation such as a gastrointestinal ulcer with different symptoms (nausea, vomiting)

Where is the study run from?
1. Universitas Padjadjaran (Indonesia)
2. Ministry of Health in Teluk Bintuni, West Papua Province (Indonesia)

When is the study starting and how long is it expected to run for?
September 2018 to November 2019

Who is funding the study?
1. Universitas Padjadjaran (Indonesia)
2. Teluk Bintuni Hospital (Indonesia)
3. Ministry for Research, Technology, and Higher Education (Indonesia)

Who is the main contact?
Rano K. Sinuraya, MPH, r.k.sinuraya@unpad.ac.id

Contact information

Dr Yasinta Rakanita
Scientific

Pharmacy Faculty of Padjadjaran University
Jatinangor-Sumedang
Jatinangor-Sumedang
45363
Indonesia

ORCID ID	0000-0002-3156-2407
Phone	+62 (0)8114533884
Email	yasinta18001@mail.unpad.ac.id

Study information

Study design	Quasi-experimental study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Adherence to iron supplementation in reproductive-age women with anemia in West Papua, Province, Indonesia
Study objectives	Sociodemographic, adherence to iron supplementation, knowledge of anemia affected to anemia recovery level.
Ethics approval(s)	Approved 15/02/2019, Padjadjaran University Research Ethics Committee (Jl. Prof. Eyckman Number 38, Bandung, 40161, Indonesia; +62 (0)22 2038697, kepk.fk.unpad@gmail.com), ref: 172/UN6.KEP/EC/2019
Health condition(s) or problem(s) studied	Moderate and severe anemia
Intervention	Participants are randomised to take one of two oral supplements daily for 30 days. The iron fumarate-folic acid (IF-FA) supplement contains the elemental iron equivalent of 30 mg and 400 µg of folic acid. The iron gluconate-multivitamins (IG-MV) supplement contains the elemental iron equivalent of 0.9 mg, 500 µg of folic acid, and multivitamins, such as 15 mg vitamin B1 HCl, 0.25 mg vitamin B2, 0.25 mg vitamin B6 HCl, 12.5 mg vitamin C, 1.5 mg calcium pantothenate, 10 mg nicotinamide, 0.5 mg folic acid, 0.65 mg cupric sulfate, and 100 mg dried beef liver. Data is collected on the factors that influence medication adherence is obtained from the calculation of the remaining tablets given for 30 days; the Medication Adherence Rating Score (MARS) tool; and the participants' perspective on adherence. For biomarker observations, hemoglobin levels are measured pre and post intervention.
Intervention type	Supplement
Primary outcome measure	Hemoglobin level measured using the portable analyzer HemoCue 201 at baseline and 30 days
Secondary outcome measures	Correlation factors to the success of anemia therapy such as ethnicity, adherence to MARS and pill counting methods, and the type of supplementation, measured at baseline and 30 days
Overall study start date	01/09/2018
Completion date	29/11/2019

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Female
Target number of participants	222
Total final enrolment	110
Key inclusion criteria	1. Moderate and severe anemia 2. Aged between 15–49 years 3. Consented to take part in the study
Key exclusion criteria	1. Did not complete the informed consent 2. Incomplete data collected pre and post session 3. Unable to communicate
Date of first enrolment	01/10/2019
Date of final enrolment	30/10/2019

Locations

Countries of recruitment

Indonesia

Study participating centre

Pusat Studi Genetik Medis, Fakultas Kedokteran Universitas Padjadjaran

Jl. Prof. Eyckman N0. 38
Bandung
40161
Indonesia

Sponsor information

Padjadjaran University
University/education

Department of Pharmacology and Clinical Pharmacy
Faculty of Pharmacy
Jl.Raya Bandung Sumedang KM. 21, Jatinangor
Sumedang
45363
Indonesia

Phone	+62 (0)84288828
Email	r.k.sinuraya@unpad.ac.id
Website	https://www.unpad.ac.id
"ROR"	https://ror.org/00xqf8t64

Teluk Bintuni General Hospital
Hospital/treatment centre

Jl. Raya Sibena KM 7, Teluk Bintuni
Teluk Bintuni, West Papua
98141
Indonesia

Phone	+62 (0)21 294 50 999
Email	eka.suradji@ukrida.ac.id

Indonesian Ministry for Research, Technology, and Higher Education
Government

Gedung D Jl. Jenderal Sudirman Pintu Satu, Senayan, Jakarta Pusat
DKI Jakarta
10270
Indonesia

Phone	+62 (0)8114533884
Email	pintu@ristekdikti.go.id
Website	https://kemendikbud.go.id

Funders

Funder type

University/education

Universitas Padjadjaran
Government organisation / Universities (academic only)

Alternative name(s): Padjadjaran University, UNPAD
Location: Indonesia

Teluk Bintuni Hospital

No information available

Kementerian Riset Teknologi Dan Pendidikan Tinggi Republik Indonesia
Government organisation / National government

Alternative name(s): Ministry of Research, Technology and Higher Education, Kementerian Ristek Dikti, Kementerian Riset dan Teknologi
Location: Indonesia

Results and Publications

Intention to publish date	17/08/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository
Publication and dissemination plan	Publication in the International Journal of Women's Health and Reproduction Sciences
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository https://repository.unpad.ac.id/ (still in maintenance).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/01/2023	20/04/2023	Yes	No

Editorial Notes

20/04/2023: Publication reference added.
24/10/2022: Trial's existence confirmed by the Padjadjaran University Research Ethics Committee.