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

Nicole Stoffel

Status: Enrolling

Conditions: Overweight and Obese Women

Treatments: Dietary Supplement: 195 mg iron daily; Dietary Supplement: 15 mg iron daily

Study type: Interventional

Funder types: Other

Identifiers

NCT07315282

FIND

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI ≥ 27.5 kg/m2
• serum ferritin <30 μg/L
• hemoglobin ≥ 11 g/dl
• fasting blood glucose < 5.6 mmol/L

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

high-dose iron supplementation

Experimental group

Description:

195 mg iron as ferrous sulfate daily for 14 days

Treatment:

Dietary Supplement: 195 mg iron daily

low-dose iron supplementation

Active Comparator group

Description:

15 mg iron as ferrous fumarate daily for 14 days

Treatment:

Dietary Supplement: 15 mg iron daily