Different Efficacy of IFA Supplementation Among Obese and Non-obese Women

The Study of Association Between Obesity and Iron Deficiency Anaemia in Nonpregnant Indonesian Women

This clinical trial aims to learn if there is a relationship between OWT/OB and IDA in nonpregnant women of reproductive age and its impact on iron supplementation. The main questions it aims to answer are:

• Is there any independent association between overweight/obesity and iron deficiency anemia in nonpregnant women after controlling for potential confounding factors?
• Does the effect of iron supplementation on iron status vary between overweight/obese and normal-weight nonpregnant women (as measured by multiple iron biomarkers)? Researchers will compare several biomarkers between the case and control groups after the intervention is given for 90 days.

Participants will:

• Visit the research center before the intervention given and after 90 days
• Take daily iron-folic acid supplements for 90 days
• Keep a diary of their supplement's intake

Study Overview

• Status: Completed
• Conditions: Anemia, Iron-Deficiency; Obesity and Overweight
• Intervention / Treatment: Dietary supplement: Iron-folic acid supplement

Detailed Description

Anaemia is one of the major nutritional problems that brings many negative health consequences to women's health, especially during pregnancy. There was growing evidence that overweight/obesity can lead to anaemia. However, the association between anaemia and overweight/obesity has not been fully established, especially in developing countries, including Indonesia. The prevalence of overweight/obesity has sharply increased in Indonesia for the past decades, while anaemia prevalence did not show a significant decrease. The prevalence of anaemia in Indonesia was still alarming, with 27.2% in nonpregnant women and 48.9% in pregnant women (Indonesia MoH, 2019a). Therefore, the study of the association between overweight/obesity and anaemia among women of reproductive age in Indonesia needs to be conducted using appropriate measurements. Furthermore, previously available studies highly ignored the role of dietary intake in the association between overweight/obesity and anaemia despite its importance. This study will also measure dietary intake among women.

Once participants agree to participate in this study, the investigators will ask questions about themselves (latest education history, employment, general health, menstrual history, smoking history, and physical activity level). The investigators will then ask the participants to write the food and beverages consumed in the dietary record form for 3-non consecutive days. Then, the investigators will ask about their dietary intake in the last 24 hours/1 day (foods the participants have taken and their approximate amount). After that, the investigators will take anthropometric measurements (height, weight, and waist circumference) to define nutritional status. The investigators will also collect a small amount (3mL) of blood samples from the participants, two times (before and after intervention). Blood collection will be performed by trained nurses/medical analysts under a medical doctor's supervision and collected at the university clinic. The investigators will measure several parameters from that blood sample, such as iron status parameters (including hemoglobin, serum ferritin, and hepcidin) and other chemicals in the blood that indicate inflammation (AGP and CRP). The results of these tests will be provided to all participants.

After collecting these data, participants will be assigned to one of the two study groups using matching criteria (age, education level, and occupation). Participants in all groups will receive iron supplements. The participants will not be made aware of which arm they have been assigned to. For the following three months, the participants will receive approximately 90 iron supplements to be consumed every day. The study staff will contact the participants through short messages and monthly visitation to ensure adherence to iron supplement consumption. After three months, the investigators will stop providing iron supplements. The investigators will collect information about their dietary intake over the last day and retake their anthropometry measurements. The investigators will also collect blood samples from participants and perform the same test as the previous one.

The investigators have asked the subjects to participate in this study because the participants are women aged between 20 and 29 years, neither pregnant nor lactating, living in this area, are healthy, have not received any micronutrient supplementation in the last three months, and have not undergoing body mass reduction or on any particular weight loss diet. After anthropometric screening, each participant will be assigned to a case or control group based on the Body Mass Index (BMI) results.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • East Java
    • Surabaya, East Java, Indonesia, 60115
      • Nutrition Laboratory, Faculty of Public Health Universitas Airlangga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Nonpregnant, nonlactating women aged 19 - 29 years
• Never been married and pregnant.
• Having no menstrual abnormality (amenorrhea, polymenorrhea, etc.)
• Able to read and write in Bahasa Indonesia
• Not undergoing body mass reduction or on any particular weight loss diet

Exclusion Criteria:

• BMI <18.5 kg/m2
• Self-reported specific diseases that need diet modification (i.e., type 1 diabetes, kidney disease, autoimmune disease, etc.)
• Self-report of significant medical conditions (e.g., diabetes mellitus, disorders of the liver [including hemochromatosis] and kidney, autoimmune or metabolic diseases, and malignancy] or use of medications that may influence weight, iron, or inflammatory status; pregnancy or lactation; vegetarianism; zinc supplementation; smoking habit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Overweight/obese arm; In this arm, those who are overweight and obese will be assigned. Each participant will be given 90 days of IFA supplement.	Dietary supplement: Iron-folic acid supplement; The major thing distinguishing this clinical study from another clinical trial is that we differentiate intervention based on nutritional status as we want to observe whether different nutritional status, especially overweight/obese will diminish the effect of IFA supplementation.
Active Comparator: Normal-weight arm; In this arm, those with normal-weight will be assigned. Each participant will be given 90 days of IFA supplement.	Dietary supplement: Iron-folic acid supplement; The major thing distinguishing this clinical study from another clinical trial is that we differentiate intervention based on nutritional status as we want to observe whether different nutritional status, especially overweight/obese will diminish the effect of IFA supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Iron Deficiency Anemia (IDA)		From enrollment to the end of treatment at 90 days
Concentration of Hemoglobin	Concentration of Hb will be measured in g/dL	Day 0 (Before intervention) and Day 90 (After intervention)
Concentration of Ferritin	Aims to assess iron deficiency among women; will be measured in ng/mL	Day 0 (Before intervention) and Day 90 (After intervention)
Concentration of Hepcidin	Concentration of Hepcidin will be measured in ng/mL	Day 0 (Before intervention) and Day 90 (After intervention)
Overweight and obese prevalence	To achieve this outcome, weight will be measured in Kilograms and height will be measured in centimeters. Weight and height will be combined to report BMI in kg/m^2.	Day 0 (Before intervention) and Day 90 (After intervention)
Concentration of CRP	The concentration of CRP will be measured in mg/L	Day 0 (Before intervention) and Day 90 (After intervention)
Concentration of AGP-1	The concentration of AGP-1 will be measured in mg/dL	Day 0 (Before intervention) and Day 90 (After intervention)

Collaborators and Investigators

• Sponsor: Griffith University
• Collaborators: Universitas Airlangga
• Investigators: Study Director: Faruk Ahmed, Convenor, Griffith University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Anemia; Indonesia; Women of reproductive age; Iron folic acid supplemet
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Hematologic Diseases; Iron Metabolism Disorders; Anemia, Hypochromic; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Hemic and Lymphatic Diseases; Iron Deficiencies; Overweight; Obesity; Anemia; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Folic Acid
• Other Study ID Numbers: GU Ref No: 2024/228; 3433/BPPT/BPI.LG/V/2024 (Other Grant/Funding Number: BPI Kemdikbud); 119/EA/KEPK/2024 (Other Identifier: KEPK FKM UNAIR); U1111-1313-7880 (Other Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD, all IPD that underlie results in a publication. All data collected from participants will only be used for research or academic purposes, i.e., publishing an article in a research journal, presenting the findings in a conference or seminar, or teaching in the classroom. Participant name and contact details will not be shown when presenting the study findings in an article or a seminar.
• IPD Sharing Time Frame: IPD and supporting information will be available from January 2025 until the next 5 years.
• IPD Sharing Access Criteria: Only the study investigators from Griffith University (QLD, Australia) will have access to your personal information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No