Clinical Trials Directory

Trials / Completed

CompletedNCT01884506

Evaluation of the Effect of Body Weight and Composition on Iron Absorption and Blood Volume

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
Swiss Federal Institute of Technology · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

A total of 75 subjects will be recruited for this study (25 normal weight, 25 overweight, 25 obese). In each subject blood volume will be determined using the minimally invasive carbon monoxide-rebreathing method (substudy 1) and iron absorption will be measured from a test meal labeled with stable iron isotopes. The effect of ascorbic acid on iron absorption will further be determined using a second labeled test meal (substudy 2). In addition, inflammation, hepcidin and iron status will be determined. In order to study the effect of body fat content on blood volume and iron absorption weight and height will be measured, and body fat will de determined by dual energy X-ray absorptiometry.

Detailed description

Obesity has repeatedly been shown to be a risk factor for iron deficiency. The reason for this is believed to be reduced iron absorption as a result of increased circulating hepcidin concentrations. However, the direct interactions between body fat mass, iron absorption, inflammation and hepcidin have not been studied to date. Whether the low iron absorption in obese subjects could be overcome by conventional methods to increasing iron absorption, e.g. the addition of ascorbic acid and whether a reduction of inflammation could improve absorption is further unclear. For the calculation of fractional iron absorption from oral doses of stable iron isotopes an estimation of blood volume is required. Several equations to estimate blood volume from weight and height or calculated body surface area or volume are available, but have rarely been validated or used in obese subjects. The aim of the described study is therefore: 1) to determine blood volume using the carbon monoxide-rebreathing method over a large BMI range and to use those values to validate existing blood volume equations; 2) to measure iron absorption, hepcidin and inflammation in relation to BMI and body fat and 3) to assess the effect of ascorbic acid on iron absorption.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTlabeled iron solutionlabeled iron as ferrous sulfate (6mg/test meal)
DIETARY_SUPPLEMENTlabeled iron solution and ascorbic acidlabeled iron as ferrous sulfate plus ascorbic acid (6mg:30mg /test meal)

Timeline

Start date
2013-06-01
Primary completion
2013-08-01
Completion
2013-10-01
First posted
2013-06-24
Last updated
2013-10-14

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT01884506. Inclusion in this directory is not an endorsement.