Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID07315282

The Effect of Oral Iron Supplements on Insulin and Glucose Metabolism in Overweight and Obese Women

Led by Nicole Stoffel · Updated on 2026-01-02

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Nicole Stoffel

Lead Sponsor

A

American University of Beirut Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how oral iron supplements affect insulin and glucose metabolism in overweight and obese women. This randomized, double-blind trial involves 70 women with a body mass index of 27.5 kg/m2 or higher, low serum ferritin, and normal fasting blood glucose levels. The study compares the effects of high-dose versus low-dose iron supplementation on blood glucose and insulin response. Participants are randomly assigned to one of two groups: one receives 195 mg of iron daily as ferrous sulfate, and the other receives 15 mg daily as ferrous fumarate. Both treatments last for 14 days. The study includes three visits: Day 0 for baseline tests, Day 14 after supplementation, and Day 17, four days after stopping the iron. Oral glucose tolerance tests (OGTT) and blood samples are collected during these visits to assess changes. Throughout the study, participants will undergo blood tests including fasting glucose, insulin levels, serum ferritin, hepcidin, and markers related to iron metabolism. The primary outcomes measure blood glucose changes during OGTT on Days 0 and 14. Additional measurements on Days 0, 14, and 17 include insulin response, inflammatory markers, and iron status indicators. This allows researchers to monitor the effects of iron supplementation over time and after cessation of treatment.

CONDITIONS

Brief Title

The Effect of Oral Iron Supplements on Insulin and Glucose Metabolism in Overweight and Obese Women

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 45 years
  • Body mass index (BMI) equal to or greater than 27.5 kg/m2
  • Serum ferritin less than 30 bcg/L
  • Hemoglobin equal to or greater than 11 g/dl
  • Fasting blood glucose less than 5.6 mmol/L
Not Eligible

You will not qualify if you...

  • Received intravenous or high dose oral iron in the previous 2 months
  • Medical disorders affecting iron absorption, metabolism, or have type 2 diabetes mellitus
  • Cigarette smoking
  • Recent blood transfusion or major blood loss

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 14 days

Participants receive daily oral iron supplements at either a high dose or low dose for 14 days.

Visits on Day 0 and Day 14 for assessments

Follow-up

Duration - 3 days

Participants undergo additional assessments 3 days after completing treatment to monitor changes in insulin and glucose metabolism.

1 visit on Day 17 (in-person)

Trial Site Locations

Total: 1 location

1

American University of Beirut

Beirut, Lebanon

Actively Recruiting

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Research Team

O

Omar Obeid

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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