The Effect of Oral Iron Supplements on Insulin and Glucose Metabolism in Overweight and Obese Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 195 mg iron daily, 15 mg iron daily.
- Who it may be relevant to
- Registry conditions: Overweight and Obese Women. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lebanon
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Dietary supplement 195 mg iron daily
3 x 65 mg iron as ferrous sulfate - Dietary supplement 15 mg iron daily
3 x 5 mg iron as ferrous sulfate
Primary outcome measures
- Blood glucose increase during OGTT Day 0 [Time frame: Day 0]
- Blood glucose increase during OGTT Day 14 [Time frame: Day 14]
Secondary outcome measures (12)
- Insulin increase during OGTT Day 0 [Time frame: Day 0]
- Insulin increase during OGTT Day 14 [Time frame: Day 14]
- Serum Hepcidin Day 0 [Time frame: Day 0]
- Serum Hepcidin D14 [Time frame: Day 14]
- Serum Ferritin Day 0 [Time frame: Day 0]
- Serum Ferritin Day 14 [Time frame: Day 14]
- Soluble Transferrin Receptor (sTfR) Day 0 [Time frame: Day 0]
- Soluble Transferrin Receptor (sTfR) Day 14 [Time frame: Day 14]
- Hemoglobin Day 0 [Time frame: Day 0]
- Hemoglobin Day 14 [Time frame: Day 14]
- C-reactive protein (CRP) Day 0 [Time frame: Day 0]
- C-reactive protein (CRP) Day 14 [Time frame: Day 14]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Lebanon · 1 center
- American University of Beirut — Beirut
Identifiers
NCT: NCT07315282 · FIND