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CompletedNCT01884506Updated Oct 14, 2013

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

An interventional study of labeled iron solution and labeled iron solution and ascorbic acid in Obesity, sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-14.

Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Obesity

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03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 64 is close to the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 152 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women
  • Age 18-45 years
  • Pre-menopausal (no absence of a menstrual cycle in the past 12 months)
  • BMI 18.5-39.9 kg/m2 (n=25 18.5-24.9, n=25 25-29.9, n=25 30-39.9)
  • Apparently healthy (no significant medical conditions that could influence iron or inflammatory status other than obesity (i.e., cancer, HIV/AIDS, inflammatory bowel disease, gastrointestinal bleeding, and rheumatoid arthritis, renal disease or hemochromatosis) (judged by study physician)

Exclusion criteria

Exclusion Criteria:

  • Moderate/sever anemia (Hb\<11 g/dl)
  • Use of medication which interferes with study measurements (judged by the study physician)
  • Smoking
  • Pregnancy and lactation; planning to become pregnant during the course of the study (pregnancy test will be conducted at visit 2 and subjects will be asked about contraception*)
  • Consumption of vitamin- or mineral supplements unless they consent to discontinue intake two weeks before the start of the study until the final blood sampling
  • Prior participation in studies using stable iron isotopes
  • Food allergies/intolerances (gluten, lactose, milk protein)
  • Blood donation during the two months prior to the study
  • Major injuries during the 6 months prior to the study
  • Illness during the 4 weeks prior to the study (judged by study physician)
  • Administration of recombinant erythropoietin (rhEPO)
  • More than 5 days at altitudes above 1600 m above sea level during the 3 weeks prior to the study
  • Long distance flight (>8 h) during the 3 weeks prior to the study
  • Chronic alcohol abuse
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    labeled iron meal

    Test meal (bread with honey) with a labeled iron solution

    Dietary Supplement: labeled iron solution · Dietary Supplement: labeled iron solution and ascorbic acid

  • Experimental
    labeled iron and ascorbic acid meal

    Test meal (bread with honey) with a labeled iron solution and ascorbic acid

    Dietary Supplement: labeled iron solution · Dietary Supplement: labeled iron solution and ascorbic acid

Interventions

  • Dietary supplementlabeled iron solution

    labeled iron as ferrous sulfate (6mg/test meal)

  • Dietary supplementlabeled iron solution and ascorbic acid

    labeled iron as ferrous sulfate plus ascorbic acid (6mg:30mg /test meal)

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What researchers measure

Primary outcomes

  1. Fractional iron absorption from the isotopically labeled test meals.

    Iron absorption will be determined by incorporation of labeled iron into erythrocytes, 14 days after the administration of the last test meal containing labeled iron (stable isotope technique). Based on the shift of the iron isotope ratios in the blood samples and the amount of iron circulating in the body, the amounts of isotopic label iron present in the blood 14 days after the test meal administration will be calculated based on the principles of isotope dilution and considering that the iron isotopic labels are not monoisotopic. Circulating iron will be calculated based on blood volume as determined by carbon monoxide-rebreathing. For calculation of fractional absorption, 80% incorporation of the absorbed iron into red blood cells will be assumed.

    Time frame: Baseline

Secondary outcomes

  1. Hemoglobin mass will be measured with the carbon monoxide-rebreathing method.

    Blood volume will be calculated from hemoglobin mass and compared to values determined by the different equations.

    Time frame: Baseline

07

Study locations

1 site
  • Human Nutrition Laboratory, ETH Zurich
    Zurich, 8092, Switzerland
08

References and documents

Publications

  • Cepeda-Lopez AC, Melse-Boonstra A, Zimmermann MB, Herter-Aeberli I. In overweight and obese women, dietary iron absorption is reduced and the enhancement of iron absorption by ascorbic acid is one-half that in normal-weight women. Am J Clin Nutr. 2015 Dec;102(6):1389-97. doi: 10.3945/ajcn.114.099218. Epub 2015 Nov 11. PubMed 26561622 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01884506
Lead sponsor
Swiss Federal Institute of Technology
Collaborators
Wageningen University, Universidad de Monterrey
Responsible party
Prof. Michael B. Zimmermann (Prof. Dr., Swiss Federal Institute of Technology) — Principal investigator
First posted
Jun 24, 2013
Start date
Jun 2013
Primary completion
Aug 2013
Completion
Oct 2013
Last update
Oct 14, 2013

Study contacts

Isabelle Aeberli, PhD
principal investigator · ETH Zurich

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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