Obesity and OverweightNCT06622551
Different Efficacy of IFA Supplementation Among Obese and Non-obese Women
A study testing Iron-folic acid supplement in people with Obesity and Overweight and Anemia, Iron-Deficiency, run by Griffith University at 1 site in Indonesia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight, Anemia, Iron-Deficiency
- What is being tested?
- Iron-folic acid supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Nutrition Laboratory, Faculty of Public Health Universitas Airlangga
Surabaya, East Java, 60115
About this study
Official title: 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.
Read more
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
Read the 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\&#39;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.
- Conditions
- Obesity and Overweight, Anemia, Iron-Deficiency
- Being tested
- Iron-folic acid supplement
- Keywords
- Obesity, Iron folic acid supplemet, Anemia, Women of reproductive age, Indonesia
- Medical subject headings
- Obesity, Overweight, Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron-folic acid supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Overweight/obese arm | Experimental | In this arm, those who are overweight and obese will be assigned. Each participant will be given 90 days of IFA supplement. Receives: Dietary Supplement: Iron-folic acid supplement |
| Normal-weight arm | Active comparator | In this arm, those with normal-weight will be assigned. Each participant will be given 90 days of IFA supplement. Receives: Dietary Supplement: Iron-folic acid supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Iron Deficiency Anemia (IDA)
Measured: From enrollment to the end of treatment at 90 days
Concentration of Hemoglobin
Concentration of Hb will be measured in g/dL
Measured: 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
Measured: Day 0 (Before intervention) and Day 90 (After intervention)
Concentration of Hepcidin
Concentration of Hepcidin will be measured in ng/mL
Measured: 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.
Measured: Day 0 (Before intervention) and Day 90 (After intervention)
Concentration of CRP
The concentration of CRP will be measured in mg/L
Measured: Day 0 (Before intervention) and Day 90 (After intervention)
Concentration of AGP-1
The concentration of AGP-1 will be measured in mg/dL
Measured: Day 0 (Before intervention) and Day 90 (After intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Griffith University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Airlangga
- Responsible party
- Principal investigator, Qonita Rachmah, Griffith University
- Investigators
- Faruk Ahmed, Convenor, Study director, Griffith University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622551
- Sponsor's protocol ID
- GU Ref No: 2024/228
- Other IDs
- 3433/BPPT/BPI.LG/V/2024, 119/EA/KEPK/2024, U1111-1313-7880
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Association Between Obesity and Iron Deficiency Anaemia in Nonpregnant Indonesian Women
- ClinicalTrials.gov ID
- NCT06622551
- Acronym / sponsor ID
- GU Ref No: 2024/228
- Conditions
- Obesity and Overweight, Anemia, Iron-Deficiency
- Keywords
- Obesity, Iron folic acid supplemet, Anemia, Women of reproductive age, Indonesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Griffith UniversityUniversity, hospital or other
- Collaborators
- Universitas Airlangga
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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\&#39;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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overweight/obese arm | Experimental | Dietary Supplement: Iron-folic acid supplementIn this arm, those who are overweight and obese will be assigned. Each participant will be given 90 days of IFA supplement. |
| Normal-weight arm | Active comparator | Dietary Supplement: Iron-folic acid supplementIn this arm, those with normal-weight will be assigned. Each participant will be given 90 days of IFA supplement. |
Who may qualify
- Ages
- 20 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron-folic acid supplementThe 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. | Dietary supplement | Normal-weight arm, Overweight/obese arm |
Primary outcome
Number of participants with Iron Deficiency Anemia (IDA)
Time frame: From enrollment to the end of treatment at 90 days
Concentration of Hemoglobin
Time frame: Day 0 (Before intervention) and Day 90 (After intervention)
Concentration of Hb will be measured in g/dL
Concentration of Ferritin
Time frame: Day 0 (Before intervention) and Day 90 (After intervention)
Aims to assess iron deficiency among women; will be measured in ng/mL
Concentration of Hepcidin
Time frame: Day 0 (Before intervention) and Day 90 (After intervention)
Concentration of Hepcidin will be measured in ng/mL
Overweight and obese prevalence
Time frame: Day 0 (Before intervention) and Day 90 (After intervention)
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.
Concentration of CRP
Time frame: Day 0 (Before intervention) and Day 90 (After intervention)
The concentration of CRP will be measured in mg/L
Concentration of AGP-1
Time frame: Day 0 (Before intervention) and Day 90 (After intervention)
The concentration of AGP-1 will be measured in mg/dL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faruk Ahmed, Convenor study director
Griffith University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron-folic acid supplement in people with Obesity and Overweight and Anemia, Iron-Deficiency, run by Griffith University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Iron Deficiency Anemia (IDA) (time frame: From enrollment to the end of treatment at 90 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.