Effects of Vitamin A and Carotenoids on Iron Absorption

NCT ID: NCT01493297

Last Updated: 2014-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-07-31

Brief Summary

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The objective of this study is to investigate the effect of vitamin A and carotenoids on iron absorption in healthy subjects with low and normal vitamin A status. Vitamin A and carotenoids have been reported to enhance the nonheme iron absorption, but the results from human isotope studies are equivocal. Radio-iron studies in Venezuelan adults have consistently reported an increase in iron absorption, whereas stable and radio isotopes studies conducted in Sweden and Switzerland reported no influence. Differences in vitamin A status of the subjects may be a possible explanation for the contradictory findings. In this study, iron absorption will be measured from an iron-fortified maize bread meal with or without retinyl palmitate or β-carotene by using both stable- and radioactive-isotope techniques in Venezuelan women with a range of vitamin A status.

Detailed Description

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Conditions

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Iron Absorption

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Retinyl palmitate

Labeled iron as FeSO4 (4 mg) added to a test meal with or without retinyl palmitate (1000 RE)

Group Type OTHER

Labeled iron solutions

Intervention Type OTHER

Labeled iron as FeSO4 (4 mg/test meal)

Beta-carotene

Labeled iron as FeSO4 (4 mg) added to a test meal with or without beta-carotene (1000 RE)

Group Type OTHER

Labeled iron solutions

Intervention Type OTHER

Labeled iron as FeSO4 (4 mg/test meal)

Interventions

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Labeled iron solutions

Labeled iron as FeSO4 (4 mg/test meal)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women 18-52 years old
* Body weight ≤ 70 kg
* Body mass index (BMI), 18.5-30 kg/m2
* Adequate vitamin A status (SR ≥ 0.7 μmol/L, n=20)
* Inadequate vitamin A status (SR \< 0.7 μmol/L, n=20)
* No major medical illnesses (no known infection, gastrointestinal or metabolic disorders)

Exclusion Criteria

* Pregnancy or lactation
* Regular intake of medication (except oral contraceptives)
* Blood donation or significant blood loss (accident, surgery) over the past 4 months
* Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
* Former participation in a study involving administration of iron stable isotopes
Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Venezolano de Investigaciones Cientificas

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Andersson, Dr

Role: PRINCIPAL_INVESTIGATOR

Swiss Federal Institute of Technology, ETH Zurich

Locations

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Venezuelan Institute for Scientific Research (IVIC)

Caracas, , Venezuela

Site Status

Countries

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Venezuela

References

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Walczyk T, Davidsson L, Rossander-Hulthen L, Hallberg L, Hurrell RF. No enhancing effect of vitamin A on iron absorption in humans. Am J Clin Nutr. 2003 Jan;77(1):144-9. doi: 10.1093/ajcn/77.1.144.

Reference Type BACKGROUND
PMID: 12499334 (View on PubMed)

Garcia-Casal MN, Layrisse M, Solano L, Baron MA, Arguello F, Llovera D, Ramirez J, Leets I, Tropper E. Vitamin A and beta-carotene can improve nonheme iron absorption from rice, wheat and corn by humans. J Nutr. 1998 Mar;128(3):646-50. doi: 10.1093/jn/128.3.646.

Reference Type BACKGROUND
PMID: 9482776 (View on PubMed)

Garcia-Casal MN. Carotenoids increase iron absorption from cereal based food in the human. Nutr Res 2006;26:340-4.

Reference Type BACKGROUND

Layrisse M, Garcia-Casal MN, Solano L, et al. The role of vitamin A on the inhibitors of nonheme iron absorption: preliminary results. J Nutr Biochem 1997;8:61-7.

Reference Type BACKGROUND

Other Identifiers

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ETH-FeVZ

Identifier Type: -

Identifier Source: org_study_id

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