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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | labeled iron solution | labeled iron as ferrous sulfate (6mg/test meal) |
| DIETARY_SUPPLEMENT | labeled iron solution and ascorbic acid | labeled 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.