The Effect of Oral Iron Supplements on Insulin and Glucose Metabolism in Overweight and Obese Women
1 other identifier
interventional
70
1 country
1
Brief Summary
The study will be a randomized, double-blind, 17-day metabolic intervention trial including 14 days of high-dose or low-dose iron supplementation. A total of 70 overweight or obese (OW/OB) women will be enrolled. Participants will be individually randomized into either the high-iron or low-iron group. Women in the low-iron group will receive 15 mg of iron as ferrous fumarate daily for 14 days, while women in the high-iron group will receive 195 mg of iron as ferrous sulfate daily for 14 days. The study consists of three visits in total. On Day 0, a fasting blood sample will be collected and an OGTT will be performed, with additional blood samples collected at 1 hour and 2 hours post-OGTT. The OGTT will be repeated on Day 14, after 14 days of oral iron supplementation, and again on Day 17, four days after oral iron supplementation has been stopped
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2025
CompletedStudy Start
First participant enrolled
December 23, 2025
CompletedFirst Posted
Study publicly available on registry
January 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
January 2, 2026
December 1, 2025
6 months
December 18, 2025
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Blood glucose increase during OGTT Day 0
Blood glucose increase during OGTT before the intake of oral iron for 14 days
Day 0
Blood glucose increase during OGTT Day 14
Blood glucose increase during OGTT after the intake of oral iron for 14 days
Day 14
Secondary Outcomes (33)
Insulin increase during OGTT Day 0
Day 0
Insulin increase during OGTT Day 14
Day 14
Serum Hepcidin Day 0
Day 0
Serum Hepcidin D14
Day 14
Serum Ferritin Day 0
Day 0
- +28 more secondary outcomes
Study Arms (2)
high-dose iron supplementation
EXPERIMENTAL195 mg iron as ferrous sulfate daily for 14 days
low-dose iron supplementation
ACTIVE COMPARATOR15 mg iron as ferrous fumarate daily for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- BMI ≥ 27.5 kg/m2
- serum ferritin \<30 μg/L
- hemoglobin ≥ 11 g/dl
- fasting blood glucose \< 5.6 mmol/L
You may not qualify if:
- intravenous or high dose oral iron in the preceding 2 months
- medical disorders are known to affect iron absorption or metabolism, or T2DM
- cigarette smoking
- recent blood transfusion or major blood loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American University of Beirut Medical Centercollaborator
- Nicole Stoffellead
Study Sites (1)
American University of Beirut
Beirut, Lebanon
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
December 18, 2025
First Posted
January 2, 2026
Study Start
December 23, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share