Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
312 participants
INTERVENTIONAL
2024-05-20
2026-01-19
Brief Summary
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Detailed Description
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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at any time during pregnancy or the occurrence of any adverse outcome such as miscarriage, the participant will be withdrawn from the study.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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Iron 25
Iron 25 (total 25 mg/d of iron): 2 supplements of 12.5 mg of elemental iron + 1 multivitamin supplement;
Adiposity and Iron Requirements in Pregnancy (ADIPREG)
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.
IRON 50
Iron 50 (total 50 mg/d of iron): 2 supplements of 25 mg of elemental iron + 1 multivitamin supplement).
Adiposity and Iron Requirements in Pregnancy (ADIPREG)
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.
Interventions
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Adiposity and Iron Requirements in Pregnancy (ADIPREG)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Solvotrin Therapeutics - Active Iron
UNKNOWN
National Health Service, United Kingdom
OTHER_GOV
University of Ulster
OTHER
Responsible Party
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Principal Investigators
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Mary McCann, PhD
Role: STUDY_DIRECTOR
University of Ulster
Locations
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Causeway Hospital
Coleraine, Co Londonderry, United Kingdom
Causeway Hospital
Coleraine, Co. Londonderry, United Kingdom
Ulster University,Human Intervention Studies Unit,
Coleraine, Co. Londonderry, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Karen Rodgers, Senior Midwife
Role: primary
Dr Jonathan White, MBChB; MRCOG
Role: primary
Karen Rodgers, Senior Midwife
Role: backup
Ruth Price, PhD
Role: primary
Geraldine Horigan, PhD
Role: backup
Other Identifiers
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FCBMS-23-259
Identifier Type: -
Identifier Source: org_study_id