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Iron Deficiency Anemia of PregnancyADIPREGNCT06425796

Adiposity and Iron Requirements in Pregnancy

A study testing Adiposity and Iron Requirements in Pregnancy (ADIPREG) in people with Iron Deficiency Anemia of Pregnancy, run by University of Ulster at 3 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to explore how body fat influences the response to either 25 or 50 mg of daily iron supplements during pregnancy. We will conduct a double-blind randomized controlled intervention study involving 312 pregnant women recruited from antenatal clinics in the Northern Trust Area. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Iron Deficiency Anemia of Pregnancy
What is being tested?
Adiposity and Iron Requirements in Pregnancy (ADIPREG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
3 sitesUnited Kingdom
Study dates
20 May 2024to 19 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • BMI ≥18.5 kg/m2
  • Without current pregnancy complications (for example, severe bleeding, Diabetes Mellitus, hyperemesis gravidarum, ectopic and molar pregnancies)
  • At least 12 Gestational Week
  • Singleton pregnancy confirmed with the first ultrasound scan
  • Participants who are currently taking multivitamins will be included. They will be asked to discontinue any current supplementation.

Who cannot join

  • Hb <110 g/L
  • SF <30 μg/L
  • High risk of iron overload (Hb >150 g/L, transferrin saturation >45% or SF> 150 μg/L)
  • Participants with history of haematological, renal, liver, autoimmune disorders, malabsorptive syndromes
  • Participants with history of bariatric surgery
  • Participants who take steroids or anti-inflammatory treatments or drugs that affect gut absorption (proton-pump inhibitors)
Show all 10Show fewer
  • Planned home births
  • Participants currently involved in another research study
  • Multiple pregnancy
  • Participants who do not speak English

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mary T McCann, PhD contact

+4402870123969

mt.mccann@ulster.ac.uk

Ruth Price, PhD contact

+442870123878

rk.price@ulster.ac.uk

United Kingdom3 sites, 3 recruiting
  • Causeway Hospital

    Coleraine, Co Londonderry, BT52 1HS

    Karen Rodgers, Senior Midwife, 02870 327032, karen.rodgers@northerntrust.hscni.net

    Recruiting
  • Causeway Hospital

    Coleraine, Co. Londonderry, BT52 1HS

    Dr Jonathan White, MBChB; MRCOG, 02870347864, jonathan.white@northerntrust.hscni.net

    Karen Rodgers, Senior Midwife, 02870 327032, karen.rodgers@northerntrust.hscni.net

    Recruiting
  • Ulster University,Human Intervention Studies Unit,

    Coleraine, Co. Londonderry, BT521SA

    Ruth Price, PhD, 00442870123878, rk.price@ulster.ac.uk

    Geraldine Horigan, PhD, +44 2870 123043 ext. 23043, gb.horigan@ulster.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Impact of Maternal Adiposity on Maternal Iron Status and Requirements: a Randomised Intervention Study

This study aims to explore how body fat influences the response to either 25 or 50 mg of daily iron supplements during pregnancy. We will conduct a double-blind randomized controlled intervention study involving 312 pregnant women recruited from antenatal clinics in the Northern Trust Area. Participants will be randomly assigned to receive either 25 or 50 mg of iron per day from 12 weeks of pregnancy until delivery, using the Active Iron supplement brand. Blood samples will be collected at 12, 28 and 36 weeks gestation and umbilical cord blood will be collected at delivery. Anthropometric measurements will be taken at each visit, and participants will complete questionnaires on various aspects of health and lifestyle, mental health, gastrointestinal symptoms, and compliance.

Read the detailed description

The main aim of this study is to investigate the influence of adiposity on the difference in response to 25 or 50 mg of daily iron supplementation during pregnancy. The primary aim is to determine the influence of maternal adiposity on adjusted maternal ferritin concentrations in response to 25 mg or 50 mg iron supplementation in pregnancy. The secondary outcomes of this study include: investigating the impact of maternal body fat on various maternal iron biomarkers (such as haemoglobin, soluble transferrin receptor, hepcidin, transferrin saturation, and other haematological markers) in response to either 25 mg or 50 mg iron supplementation during pregnancy, evaluating changes in adjusted ferritin concentrations and other iron markers throughout pregnancy relative to the dosage of iron supplementation received, determining the effect of maternal body fat on neonatal iron biomarkers in response to maternal iron supplementation, assessing changes in markers of inflammation in response to iron supplementation during pregnancy, and examine changes in mental health scores in response to iron supplementation during pregnancy.

This is a double-blind randomised controlled intervention study, in which 312 pregnant women with singleton pregnancy, without current complications, aged ≥ 18 years and BMI ≥ 18.5 kg/m2 will be recruited. Participants who are taking multivitamins will be included. They will be asked to discontinue any current supplementation. Pregnant women with anaemia, iron deficiency, high risk of iron overload, history of bariatric surgery, who are planning home birth, are currently involved in another research study, and those who cannot speak or understand English language will be excluded.

Blood samples and anthropometric and body composition measurements will be taken at different points in the pregnancy (12, 28, 36 gestational weeks) and an umbilical cord blood sample at the time of birth. Blood concentrations of iron and inflammation markers will be analysed. General, dietary intake and lifestyle information will be collected, through a Health and Lifestyle questionnaire and a 4-day diary. Additionally, participants will complete a questionnaire about their mental health and gastrointestinal symptoms. The compliance of the supplementation will be evaluated at each timepoint. Additionally, participants will receive a telephone call to evaluate possible adverse effects and compliance of the supplementation between the timepoints (18, 24 and 32 weeks of gestation). In the event that a participant has been prescribed iron treatment, anaemia diagnosis at any time during pregnancy or the occurrence of any adverse outcome such as miscarriage, the participant will be withdrawn from the study. Electronic forms prepared in RedCap will be used to collect data.

Amendment to above protocol:

Removal of one of the exclusion criteria of the study: having a ferritin concentration < 30 ug/L at time of enrolment. Currently, ferritin is not part of routine investigations at any time during pregnancy, unless there are risk factors for iron deficiency (Pavord et al 2019).

Excluding pregnant women with low iron levels will select a very low risk population of developing iron deficiency, and therefore, they will not reflect the real effect of the intervention in this population.

  1. Include an 8 week postpartum sampling timepoint. The intervention will conclude as originally planned during the delivery and will not be extended. An additional timepoint will be offered and explained to participants who are already enrolled, but they will not be obligated to participate.

Postpartum anemia affects 25-30% of women (Bodnar et al., 2005). Additionally, recent unpublished data from Northern Ireland shows that 80% of women receiving 17 mg/day of iron supplementation throughout pregnancy were iron deficient by 36 weeks, with even higher rates among pregnant women with obesity. Given these findings, we will extend our assessment of iron status after the intervention by adding this postpartum timepoint.

Being tested
Adiposity and Iron Requirements in Pregnancy (ADIPREG)
Keywords
Iron status, Iron Supplements, Pregnancy, Anaemia, Maternal obesity, Maternal Overweight, Body composition, Ferritin, Inflammation, Mental Health, Neonatal anaemia
Medical subject headings
Anemia, Pregnancy in Obesity, Inflammation, Psychological Well-Being, Anemia, Neonatal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adiposity and Iron Requirements in Pregnancy (ADIPREG)Dietary supplement

    Iron 25 arm will receive: two iron supplements containing 12.5 mg of elemental iron + 1 multivitamin supplement (they will receive a total of 3 supplements per day).

    Iron 50 arm will receive: two 25 mg elemental iron supplements + 1 multivitamin supplement (they will receive a total of 3 supplements per day).

    The multivitamin supplement will contain folic acid, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B12, vitamin C and vitamin D. In summary, each participant will receive 3 supplements per day and instructed to take the 3 supplements together, in the morning, with breakfast. Supplements will be given to the participants when they attend for their clinic appointment. The intervention will begin at 12 gestational weeks and continue until the baby is delivered.

Study groups in NCT06425796
Study groupRoleWhat they receive
Iron 25Active comparatorIron 25 (total 25 mg/d of iron): 2 supplements of 12.5 mg of elemental iron + 1 multivitamin supplement;
Receives: Dietary Supplement: Adiposity and Iron Requirements in Pregnancy (ADIPREG)
IRON 50Active comparatorIron 50 (total 50 mg/d of iron): 2 supplements of 25 mg of elemental iron + 1 multivitamin supplement).
Receives: Dietary Supplement: Adiposity and Iron Requirements in Pregnancy (ADIPREG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. * - Adjusted maternal ferritin concentrations in response to iron supplementation (ng/mL)

    Assessed via electrochemiluminescence immunoassay "ECLIA".

    Measured: 16, 24 and 28 weeks after baseline

Secondary outcomes (14)
  1. Hemoglobin (g/L)

    Assessed via Direct Current sheat flow method (Sysmex)

    Measured: 16, 24 and 28 weeks after baseline

  2. Red blood cell count (RBC) (10^12/L)

    Assessed via Direct Current sheat flow method (Sysmex)

    Measured: 16, 24 and 28 weeks after baseline.

  3. Mean cell haemoglobin (MCH) (pg

    Assessed via Direct Current sheat flow method (Sysmex)

    Measured: 16, 24 and 28 weeks after baseline.

  4. Mean cell volume (MCV) (fl)

    Assessed via Direct Current sheat flow method (Sysmex)

    Measured: 16, 24 and 28 weeks after baseline.

  5. Mean cell haemoglobin concentrations (MCHC) (g/dL)

    Assessed via Direct Current sheat flow method (Sysmex)

    Measured: 16, 24 and 28 weeks after baseline.

  6. Red cell distribution width (RDW) (%)

    Assessed via Direct Current sheat flow method (Sysmex)

    Measured: 16, 24 and 28 weeks after baseline.

  7. Transferrin (g/L)

    Assessed via immunoturbidimety assay

    Measured: 16, 24 and 28 weeks after baseline.

  8. Serum iron (umol/L)

    Assessed via colorimetic assay

    Measured: 16, 24 and 28 weeks after baseline.

  9. sTfR (ug/mL)

    Assessed via ELISA

    Measured: 16, 24 and 28 weeks after baseline.

  10. Hepcidin (pg/mL)

    Assessed via ELISA

    Measured: 16, 24 and 28 weeks after baseline.

  11. C-reactive protein (mg/mL)

    Assessed via ELISA

    Measured: 16, 24 and 28 weeks after baseline.

  12. Pro- anti- inflammatory biomarkers: IL-1 β, IL-6, IL-10, IL-22, IL-17, TNF- α, IFN- γ (fg/mL)

    Assessed via sandwich immunoassay

    Measured: 16, 24 and 28 weeks after baseline.

  13. Genetic variants of interest in relation to obesity and iron metabolism in response to iron supplementation.

    Assessed via methylation analyses

    Measured: 16, 24 and 28 weeks after baseline.

  14. Mental health score in response to iron supplementation

    CORE 10 questionnaire will be completed by each participant at each timepoint: CORE stands for "Clinical Outcomes in Routine Evaluation." The CORE-10 is a 10-item assesses psychological distress over the past week. The resulting score can be divided into categories with increasing severity: Healthy (0-5), low (6-10), mild (11-14), moderate (15-19), moderate-to-severe (20-24), and severe (25 and above). The score of this questionnaire will be collected as a numeric variable.

    Measured: 16, 24 and 28 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2024
  2. Study start20 May 2024
  3. Primary completion19 Jan 2027 (estimated)
  4. Study completion19 Mar 2027 (estimated)

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
312 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06425796
Sponsor's protocol ID
FCBMS-23-259
Acronym
ADIPREG
Status last verified
Jun 2026
First submitted
9 May 2024
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Adiposity and Iron Requirements in Pregnancy (ADIPREG) in people with Iron Deficiency Anemia of Pregnancy, run by University of Ulster at 3 sites in United Kingdom.

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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 1 Jul 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 United Kingdom. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mary T McCann, PhD (+4402870123969, mt.mccann@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

* - Adjusted maternal ferritin concentrations in response to iron supplementation (ng/mL) (time frame: 16, 24 and 28 weeks after baseline). 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 1 Jul 2026.

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