Iron Deficiency Anaemia Due to Dietary CausesIFA-AG-CoastalNCT07903558
Prevalence and Impact of Micronutrient (Iron-Folic Acid) Deficiencies on the Health of Adolescent Girls in Coastal Areas of Bangladesh
A study testing Iron-Folic Acid and Zinc Supplementation and Vitamin C Supplementation in people with Iron Deficiency Anaemia Due to Dietary Causes and Folic Acid Deficiency Anemia, Dietary, run by Patuakhali Science and Technology University at 1 site in Bangladesh.
Trial summary
Anemia and iron-folic acid (IFA) deficiencies are major nutritional concerns among adolescent girls in environmentally vulnerable coastal communities of Bangladesh. However, evidence on anemia prevalence and health outcomes in relation to iron-folic acid (IFA) supplement receipt remains limited. Read more about this study
- Who is it for?
- Ages 11 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anaemia Due to Dietary Causes, Folic Acid Deficiency Anemia, Dietary, Anemia
- What is being tested?
- Iron-Folic Acid and Zinc Supplementation and Vitamin C Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jan 2026to 30 Jul 2026
- 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 11 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Only coastal teenage girls between the ages of 11 and 19 who had resided in the study area for at least a year before data collection were included. Participants who provided informed consent/assent by legal guardian and were willing to participate in the intervention and also complete the three-month follow-up assessment were included in the study.
Who cannot join
- Participants were excluded if they had severe chronic illnesses or diagnosed medical conditions that could affect on hematological status, were currently receiving iron, folic acid, or other micronutrient-containing supplements/medications, or had incomplete baseline or follow-up data required for analysis
Trial locations and contacts
1 site in 1 country.
About this study
Anemia and iron-folic acid (IFA) deficiencies are major nutritional concerns among adolescent girls in environmentally vulnerable coastal communities of Bangladesh. However, evidence on anemia prevalence and health outcomes in relation to iron-folic acid (IFA) supplement receipt remains limited.
Objectives: This study aimed to assess IFA deficiency-related health problems and the impact of IFA supplementation on hematological, nutritional, and overall health outcomes among adolescent girls in coastal Bangladesh Methods: A randomized controlled trial study was conducted among 440 adolescent girls from Patuakhali, Bagerhat, Noakhali, and Cox's Bazar districts of Bangladesh. In each district, 60 participants were assigned to the IFA intervention group and 60 to the control group. The intervention group received IFA for three months, with assessments of hemoglobin, anemia, nutritional status, and health outcomes.
- Conditions
- Iron Deficiency Anaemia Due to Dietary Causes, Folic Acid Deficiency Anemia, Dietary, Anemia
- Being tested
- Iron-Folic Acid and Zinc Supplementation, Vitamin C Supplementation
- Keywords
- Iron-folic acid supplementation, Vitamin C, Randomized controlled trial, Dietary intake, Micronutrient deficiency, CBC
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron-Folic Acid and Zinc SupplementationDietary supplement
Participants received daily capsules containing 47 mg elemental iron, 500 µg folic acid, and 22.5 mg zinc for three months. Adherence and adverse events were monitored.
Vitamin C SupplementationDietary supplement
Participants received Vitamin C 500 mg daily for three months.
| Study group | Role | What they receive |
|---|---|---|
| Iron-Folic Acid and Zinc Supplementation Group | Experimental | Arm 1 - Intervention group Receives: Dietary Supplement: Iron-Folic Acid and Zinc Supplementation |
| Vitamin C Supplementation | Placebo comparator | Participants received Vitamin C 500 mg daily for three months Receives: Dietary Supplement: Vitamin C Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin Concentration from Baseline to 3 Months
Change in hemoglobin concentration from baseline to the 3-month follow-up assessment. Hemoglobin concentration will be measured using a calibrated automated hematology analyzer. The change will be calculated as the hemoglobin concentration at 3 months minus the baseline hemoglobin concentration.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anaemia Due to Dietary CausesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial (cRCT)
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patuakhali Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903558
- Sponsor's protocol ID
- PSTU/RTC-B/01/15/25/19
- Acronym
- IFA-AG-Coastal
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. The study data will be used for the planned analyses and reporting of study findings. Data sharing may be considered in the future, subject to ethical approval, institutional policies, and protection of participants' confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact of Micronutrient (Iron-Folic Acid) Deficiencies on the Health of Adolescent Girls in Coastal Areas of Bangladesh
- ClinicalTrials.gov ID
- NCT07903558
- Acronym / sponsor ID
- IFA-AG-Coastal / PSTU/RTC-B/01/15/25/19
- Conditions
- Iron Deficiency Anaemia Due to Dietary Causes, Folic Acid Deficiency Anemia, Dietary, Anemia
- Keywords
- Iron-folic acid supplementation, Vitamin C, Randomized controlled trial, Dietary intake, Micronutrient deficiency, CBC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Patuakhali Science and Technology UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 29 Oct 2026 (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.
Anemia and iron-folic acid (IFA) deficiencies are major nutritional concerns among adolescent girls in environmentally vulnerable coastal communities of Bangladesh. However, evidence on anemia prevalence and health outcomes in relation to iron-folic acid (IFA) supplement receipt remains limited.
Objectives: This study aimed to assess IFA deficiency-related health problems and the impact of IFA supplementation on hematological, nutritional, and overall health outcomes among adolescent girls in coastal Bangladesh Methods: A randomized controlled trial study was conducted among 440 adolescent girls from Patuakhali, Bagerhat, Noakhali, and Cox's Bazar districts of Bangladesh. In each district, 60 participants were assigned to the IFA intervention group and 60 to the control group. The intervention group received IFA for three months, with assessments of hemoglobin, anemia, nutritional status, and health outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial (cRCT)
| Arm | Type | Receives |
|---|---|---|
| Iron-Folic Acid and Zinc Supplementation Group | Experimental | Dietary Supplement: Iron-Folic Acid and Zinc SupplementationArm 1 - Intervention group |
| Vitamin C Supplementation | Placebo comparator | Dietary Supplement: Vitamin C SupplementationParticipants received Vitamin C 500 mg daily for three months |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Only coastal teenage girls between the ages of 11 and 19 who had resided in the study area for at least a year before data collection were included. Participants who provided informed consent/assent by legal guardian and were willing to participate in the intervention and also complete the three-month follow-up assessment were included in the study.
Key exclusion criteria (1 listed)
- Participants were excluded if they had severe chronic illnesses or diagnosed medical conditions that could affect on hematological status, were currently receiving iron, folic acid, or other micronutrient-containing supplements/medications, or had incomplete baseline or follow-up data required for analysis
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 and Zinc SupplementationParticipants received daily capsules containing 47 mg elemental iron, 500 µg folic acid, and 22.5 mg zinc for three months. Adherence and adverse events were monitored. | Dietary supplement | Iron-Folic Acid and Zinc Supplementation Group |
| Vitamin C SupplementationParticipants received Vitamin C 500 mg daily for three months. | Dietary supplement | Vitamin C Supplementation |
Primary outcome
Change in Hemoglobin Concentration from Baseline to 3 Months
Time frame: Baseline to 3 months
Change in hemoglobin concentration from baseline to the 3-month follow-up assessment. Hemoglobin concentration will be measured using a calibrated automated hematology analyzer. The change will be calculated as the hemoglobin concentration at 3 months minus the baseline hemoglobin concentration.
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 29 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. The study data will be used for the planned analyses and reporting of study findings. Data sharing may be considered in the future, subject to ethical approval, institutional policies, and protection of participants' confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Zinc Supplementation and Vitamin C Supplementation in people with Iron Deficiency Anaemia Due to Dietary Causes and Folic Acid Deficiency Anemia, Dietary, run by Patuakhali Science and Technology University at 1 site in Bangladesh.
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 1 inclusion and 1 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 29 Oct 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 Bangladesh. 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. Some participants in this study may receive a placebo. 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?
Change in Hemoglobin Concentration from Baseline to 3 Months (time frame: Baseline to 3 months). 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 29 Oct 2026.