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New treatment option for Iron Deficiency Anemia of Pregnancy
Official title Adiposity and Iron Requirements in Pregnancy
ClinicalTrials.gov ID: NCT06425796
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Coleraine, Co Londonderry, United Kingdom
- Coleraine, Co. Londonderry, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Coleraine, Co Londonderry, United Kingdom; Coleraine, Co. Londonderry, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.