Impact of Maternal Adiposity on Maternal Iron Status and Requirements: a Randomised Intervention Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
United Kingdom
Causeway Hospital
RECRUITING
Coleraine
Causeway Hospital
RECRUITING
Coleraine
Ulster University,Human Intervention Studies Unit,
RECRUITING
Coleraine
Contact Information
Primary
Mary T McCann, PhD
mt.mccann@ulster.ac.uk
+4402870123969
Backup
Ruth Price, PhD
rk.price@ulster.ac.uk
+442870123878
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2026-01-19
Participants
Target number of participants: 312
Treatments
Active_comparator: Iron 25
Iron 25 (total 25 mg/d of iron): 2 supplements of 12.5 mg of elemental iron + 1 multivitamin supplement;
Active_comparator: IRON 50
Iron 50 (total 50 mg/d of iron): 2 supplements of 25 mg of elemental iron + 1 multivitamin supplement).
Sponsors
Collaborators: Solvotrin Therapeutics - Active Iron, National Health Service, United Kingdom
Leads: University of Ulster

This content was sourced from clinicaltrials.gov