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Adiposity and Iron Requirements in Pregnancy

NCT06425796 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2024-12-17

No results posted yet for this study

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

Interventions

DIETARY_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.

Sponsors & Collaborators

  • Solvotrin Therapeutics - Active Iron

    collaborator UNKNOWN

  • National Health Service, United Kingdom

    collaborator OTHER_GOV

  • University of Ulster

    lead OTHER

Principal Investigators

  • Mary McCann, PhD · University of Ulster

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2026-01-19
Completion
2026-01-19

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06425796 on ClinicalTrials.gov