Adiposity and Iron Requirements in Pregnancy
ConditionIron Deficiency Anemia of Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Ulster
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Adiposity and Iron Requirements in Pregnancy (ADIPREG)
Dietary supplementIron 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.
Treatment groups
312 Participants
are divided into 2 treatment groupsGroup A: Iron 25Active comparator 1 intervention
Group B: IRON 50Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
* - Adjusted maternal ferritin concentrations in response to iron supplementation (ng/mL)
Assessed via electrochemiluminescence immunoassay "ECLIA".
Time frame
16, 24 and 28 weeks after baselineSecondary outcomes
1
Hemoglobin (g/L)
Assessed via Direct Current sheat flow method (Sysmex)
Time frame
16, 24 and 28 weeks after baseline2
Red blood cell count (RBC) (10^12/L)
Assessed via Direct Current sheat flow method (Sysmex)
Time frame
16, 24 and 28 weeks after baseline.3
Mean cell haemoglobin (MCH) (pg
Assessed via Direct Current sheat flow method (Sysmex)
Time frame
16, 24 and 28 weeks after baseline.4
Mean cell volume (MCV) (fl)
Assessed via Direct Current sheat flow method (Sysmex)
Time frame
16, 24 and 28 weeks after baseline.Other outcomes
1
Adjusted maternal ferritin concentrations in response to iron supplementation (ng/mL)
Assessed via ELISA analyses for ferritin concentration
Time frame
16, 24 and 28 weeks after baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Ulster
Lead sponsor
Solvotrin Therapeutics - Active Iron
Collaborator
National Health Service, United Kingdom
Collaborator
Source ClinicalTrials.gov