CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Ferrous sulphatedietary
Likely dose
Not stated in record
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Search/NCT05238987
NCT05238987N/ACompleted

Acute Effect of a Single Dose of Oral Iron on Pancreatic Beta Cell Function in Healthy Individuals: a Quasi-experimental Single Arm Before-and-after (Pre-post) Study

Christian Medical College, Vellore, India·interventional·Posted Feb 14, 2022·Updated Mar 2, 2022

In Brief

A clinical study evaluating Ferrous sulphate for Insulin Secretion. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Oral supplementation with highly bioavailable forms of iron, such as ferrous sulphate, is the treatment of choice for iron-deficiency anemia. Iron from ferrous sulphate is efficiently absorbed in the duodenum, resulting in a rapid increase in transferrin saturation and appearance of "free iron" or non-transferrin bound iron (NTBI) in blood. NTBI is highly reactive and can catalyze the generation of reactive oxygen species and cause oxidative tissue damage. Human pancreatic beta cells are known to express ZIP14, a transporter that has been implicated in uptake of NTBI from blood. In vitro and animal studies have shown that iron loading in beta cells can result in impaired insulin secretion. However, there are no human studies that have looked at the acute effects of oral iron intake on insulin secretion. In this study, we plan to look at the effect of a single oral dose of ferrous sulphate on insulin secretion kinetics in healthy individuals. A single arm before-and-after (pre-post) study design will be used. Consenting individuals who meet the participation criteria will undergo a 75g oral glucose tolerance test (OGTT) to document baseline insulin secretion kinetics. One week later, OGTT will be repeated after administering a single dose of ferrous sulphate (120 mg of elemental iron) 2 hours prior to the test. Iron-induced change in insulin secretion kinetics will be documented. In addition, we will determine changes in glucose tolerance, insulin resistance and insulin clearance rates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 14, 2022
Enrollment StartOct 10, 2020
Primary CompletionSep 16, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.4 years ago

Interventions

Ferrous sulphatedietary

Single dose of ferrous sulphate (120 mg of elemental iron)