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Pregnancy iron study: does body fat change supplement needs?

NCT ID NCT06425796

Knowledge-focused Sponsor: University of Ulster Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study investigates whether a pregnant woman's body fat influences how well she responds to daily iron supplements. Over 300 pregnant women will take either 25 mg or 50 mg of iron each day from week 12 until delivery. Researchers will track iron levels in blood and other health measures to see if different doses work better depending on body composition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iron supplement (25 mg or 50 mg elemental iron daily)
What this could lead to
If successful, this could help tailor iron supplement doses for pregnant women based on body fat, potentially reducing iron deficiency anemia.
What could go wrong
This is an early-stage observational-style trial, not designed to prove a cure or major health outcome. Results may not change current guidelines.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 312 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria:- Pregnant women * 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. Exclusion Criteria: * 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) * Planned home births * Participants currently involved in another research study * Multiple pregnancy * Participants who do not speak English

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Conditions

The condition(s) this trial relates to.

anemia Inflammation iron deficiency anemia neonatal anemia Pregnancy in Obesity Psychological Well-Being

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Iron deficiency anemia of pregnancy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Causeway Hospital

    RECRUITING

    Coleraine, Co Londonderry, BT52 1HS, United Kingdom

  • Causeway Hospital

    RECRUITING

    Coleraine, Co. Londonderry, BT52 1HS, United Kingdom

  • Ulster University,Human Intervention Studies Unit,

    RECRUITING

    Coleraine, Co. Londonderry, BT521SA, United Kingdom

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