Adiposity and Iron Requirements in Pregnancy

NCT06425796 | Recruiting

• 1 other identifier: FCBMS-23-259
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Iron Deficiency Anemia of Pregnancy

Keywords

Iron status; Iron Supplements; Pregnancy; Anaemia; Maternal obesity; Maternal Overweight; Body composition; Ferritin; Inflammation; Mental Health; Neonatal anaemia

Outcome Measures

Primary Outcomes (1)

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

  Assessed via electrochemiluminescence immunoassay "ECLIA".

  16, 24 and 28 weeks after baseline

Secondary Outcomes (14)

• Hemoglobin (g/L)

  16, 24 and 28 weeks after baseline

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

  16, 24 and 28 weeks after baseline.

• Mean cell haemoglobin (MCH) (pg

  16, 24 and 28 weeks after baseline.

• Mean cell volume (MCV) (fl)

  16, 24 and 28 weeks after baseline.

• Mean cell haemoglobin concentrations (MCHC) (g/dL)

  16, 24 and 28 weeks after baseline.

Other Outcomes (1)

• Adjusted maternal ferritin concentrations in response to iron supplementation (ng/mL)

  16, 24 and 28 weeks after baseline

Study Arms (2)

Iron 25

ACTIVE COMPARATOR

Iron 25 (total 25 mg/d of iron): 2 supplements of 12.5 mg of elemental iron + 1 multivitamin supplement;

Dietary Supplement: Adiposity and Iron Requirements in Pregnancy (ADIPREG)

IRON 50

ACTIVE COMPARATOR

Iron 50 (total 50 mg/d of iron): 2 supplements of 25 mg of elemental iron + 1 multivitamin supplement).

Dietary Supplement: Adiposity and Iron Requirements in Pregnancy (ADIPREG)

Interventions

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.

IRON 50; Iron 25

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: only female participants are being studied
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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)
• Planned home births
• Participants currently involved in another research study
• Multiple pregnancy
• Participants who do not speak English

Sponsors & Collaborators

• University of Ulster: lead
• Solvotrin Therapeutics - Active Iron: collaborator
• National Health Service, United Kingdom: collaborator

Study Sites (3)

Causeway Hospital

Coleraine, Co Londonderry, BT52 1HS, United Kingdom

RECRUITING

Causeway Hospital

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

RECRUITING

Ulster University,Human Intervention Studies Unit,

Coleraine, Co. Londonderry, BT521SA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anemia; Pregnancy in Obesity; Inflammation; Psychological Well-Being; Anemia, Neonatal

Interventions

Adiposity; Pregnancy

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Personal Satisfaction; Behavior; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Mary McCann, PhD

  University of Ulster

  STUDY DIRECTOR

Central Study Contacts

Mary T McCann, PhD

CONTACT

+4402870123969; mt.mccann@ulster.ac.uk

Ruth Price, PhD

CONTACT

+442870123878; rk.price@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind: two or more parties are unaware of the intervention assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 22, 2024
• Study Start: May 20, 2024
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)