Iron Deficiency (Without Anemia)Phase 4FAIRNCT04228627
Ferritin Screening And IRon Treatment for Maternal Anemia and FGR Prevention Trial
A Phase 4 study testing Parentral Iron in people with Iron Deficiency (Without Anemia) and Pregnancy Related, run by Services Institute of Medical Sciences, Pakistan at 3 sites in Pakistan.
Trial summary
Prevalence of anemia in Asia is more than 50%. All woman who book for antenatal care with non-anaemic iron deficiency (NAID) can be offered therapeutic doses of parentral iron, as a directly observed complete therapy, to prevent of maternal anaemia and fetal growth restriction. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron Deficiency (Without Anemia), Pregnancy Related
- What is being tested?
- Parentral Iron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesPakistan
- Study dates
- 14 Jan 2020to 28 Feb 2024
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Non-anaemic iron deficiency
Who cannot join
- Anaemia or normal iron stores
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Fatima Jinnah Medical University
Lahore, Punjab Province, 54000
TAYYIBA Wasim
Lahore, Punjab Province, 54590
Allama Iqbal Medical College
Lahore, Punjab Province
About this study
Official title: Intravenous Iron for Non-anaemic Iron Deficiency in Pregnancy:a Multicenter,Two-arm,Randomised Controlled Trial
Prevalence of anemia in Asia is more than 50%. All woman who book for antenatal care with non-anaemic iron deficiency (NAID) can be offered therapeutic doses of parentral iron, as a directly observed complete therapy, to prevent of maternal anaemia and fetal growth restriction. The investigators will compare this intervention with usual care in a multicentre randomised trial.
Read the detailed description
Prevalence of anemia (haemoglobin less than 11 gm/dl) in Asia is more than 50% and non-anaemic iron deficiency (ferritin less than 30 microgm/l) or NAID is likely to be more prevalent than this figure. It has been hypothesised that NAID in pregnancy can be linked to maternal fatigue and anaemia, and infant birth weight and growth restriction. The investigators will compare, in NAID, active intervention (therapeutic doses of parentral iron, as a directly observed complete therapy, to replenish iron stores) vs usual care (prophylactic oral iron supplementation) to prevent of maternal anaemia and fetal growth restriction in a multicentre randomised trial.
- Being tested
- Parentral Iron
- Keywords
- anemia, ferritin
- Medical subject headings
- Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parentral IronDrug
Correction of Iron stores without anaemia
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Intravenous Iron to correct Iron deficiency without anaemia Receives: Drug: Parentral Iron |
| Prophylaxis | No intervention | Usual antenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal anaemia
Haemoglobin concentration (g/dl)
Measured: 36 weeks' gestation
Secondary outcomes (1)
Fetal growth restriction
Birthweight for gestational age (percentile)
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start14 Jan 2020
- Primary completion30 Jan 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency (Without Anemia)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi centre randomised trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Collaborators
- Allama Iqbal Medical College, Universidad de Granada, Fatima Jinnah Medical University
- Responsible party
- Principal investigator, Tayyiba Wasim, Services Institute of Medical Sciences, Pakistan
- Investigators
- TAYYIBA Wasim, Principal investigator, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228627
- Sponsor's protocol ID
- IRB/2019/599/SIMS
- Acronym
- FAIR
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2020
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On completion of study we will happily discuss data sharing with any legitimate party with an IPD meta-analysis protocol.
Publications
Pratt JJ, Khan KS. Non-anaemic iron deficiency - a disease looking for recognition of diagnosis: a systematic review. Eur J Haematol. 2016 Jun;96(6):618-28. doi: 10.1111/ejh.12645. Epub 2015 Sep 17.
PubMed 26256281Wasim T, Bushra N, Tajammul A, Humayun S, Rasool S, Shahbaz F, Riaz A, Siddique F, Khawaja KI, Fatima A, Zafar Z, Khan KS. Ferritin screening and Iron treatment for maternal anemia and fetal growth restriction prevention - A multicenter randomized controlled trial (FAIR Study). Pak J Med Sci. 2023 Jan-Feb;39(1):293-299. doi: 10.12669/pjms.39.1.6686.
PubMed 36694741Wasim T, Bushra N, Nasrin T, Humayun S, Tajammul A, Khawaja KI, Irshad S, Fatima S, Yasin A, Zamora J, Cano-Ibanez N, Fernandez-Felix BM, Khan KS; Ferritin screening and iron treatment for maternal anaemia and fetal growth restriction prevention (FAIR) Study Group. Intravenous iron for non-anaemic iron deficiency in pregnancy: a multicentre, two-arm, randomised controlled trial. Lancet Haematol. 2026 Jan;13(1):e22-e29. doi: 10.1016/S2352-3026(25)00315-1.
PubMed 41482443
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Iron for Non-anaemic Iron Deficiency in Pregnancy:a Multicenter,Two-arm,Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04228627
- Acronym / sponsor ID
- FAIR / IRB/2019/599/SIMS
- Keywords
- anemia, ferritin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Collaborators
- Allama Iqbal Medical College, Universidad de Granada, Fatima Jinnah Medical University
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 14 Jan 2020 (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.
Prevalence of anemia in Asia is more than 50%. All woman who book for antenatal care with non-anaemic iron deficiency (NAID) can be offered therapeutic doses of parentral iron, as a directly observed complete therapy, to prevent of maternal anaemia and fetal growth restriction. The investigators will compare this intervention with usual care in a multicentre randomised trial.
Detailed description
Prevalence of anemia (haemoglobin less than 11 gm/dl) in Asia is more than 50% and non-anaemic iron deficiency (ferritin less than 30 microgm/l) or NAID is likely to be more prevalent than this figure. It has been hypothesised that NAID in pregnancy can be linked to maternal fatigue and anaemia, and infant birth weight and growth restriction. The investigators will compare, in NAID, active intervention (therapeutic doses of parentral iron, as a directly observed complete therapy, to replenish iron stores) vs usual care (prophylactic oral iron supplementation) to prevent of maternal anaemia and fetal growth restriction in a multicentre randomised trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Multi centre randomised trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Parentral IronIntravenous Iron to correct Iron deficiency without anaemia |
| Prophylaxis | No intervention | –Usual antenatal care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non-anaemic iron deficiency
Key exclusion criteria (1 listed)
- Anaemia or normal iron stores
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 |
|---|---|---|
| Parentral IronCorrection of Iron stores without anaemia | Drug | Treatment |
Primary outcome
Maternal anaemia
Time frame: 36 weeks' gestation
Haemoglobin concentration (g/dl)
1 secondary outcome
Fetal growth restriction
Time frame: At birth
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 15 Jan 2026.
- Background: PubMed 26256281Pratt JJ, Khan KS. Non-anaemic iron deficiency - a disease looking for recognition of diagnosis: a systematic review. Eur J Haematol. 2016 Jun;96(6):618-28. doi: 10.1111/ejh.12645. Epub 2015 Sep 17.
- Background: PubMed 36694741Wasim T, Bushra N, Tajammul A, Humayun S, Rasool S, Shahbaz F, Riaz A, Siddique F, Khawaja KI, Fatima A, Zafar Z, Khan KS. Ferritin screening and Iron treatment for maternal anemia and fetal growth restriction prevention - A multicenter randomized controlled trial (FAIR Study). Pak J Med Sci. 2023 Jan-Feb;39(1):293-299. doi: 10.12669/pjms.39.1.6686.
- Derived from this study: PubMed 41482443Wasim T, Bushra N, Nasrin T, Humayun S, Tajammul A, Khawaja KI, Irshad S, Fatima S, Yasin A, Zamora J, Cano-Ibanez N, Fernandez-Felix BM, Khan KS; Ferritin screening and iron treatment for maternal anaemia and fetal growth restriction prevention (FAIR) Study Group. Intravenous iron for non-anaemic iron deficiency in pregnancy: a multicentre, two-arm, randomised controlled trial. Lancet Haematol. 2026 Jan;13(1):e22-e29. doi: 10.1016/S2352-3026(25)00315-1.
- Individual participant dataSharing planned: Yes. On completion of study we will happily discuss data sharing with any legitimate party with an IPD meta-analysis protocol.
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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.
TAYYIBA Wasim principal investigator
Services Institute of Medical Sciences, Pakistan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Parentral Iron in people with Iron Deficiency (Without Anemia) and Pregnancy Related, run by Services Institute of Medical Sciences, Pakistan at 3 sites in Pakistan.
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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maternal anaemia (time frame: 36 weeks' gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04228627, which also lists 3 linked publications.
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 15 Jan 2026.