Iron Absorption Clinical Trial
Official title:
Effects of Vitamin A and Carotenoids on Iron Absorption
Verified date | January 2014 |
Source | Swiss Federal Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | July 2012 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 52 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Venezuela | Venezuelan Institute for Scientific Research (IVIC) | Caracas |
Lead Sponsor | Collaborator |
---|---|
Swiss Federal Institute of Technology | Instituto Venezolano de Investigaciones Cientificas |
Venezuela,
García-Casal MN, Layrisse M, Solano L, Barón MA, Arguello F, Llovera D, Ramírez 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. — View Citation
Garcia-Casal MN. Carotenoids increase iron absorption from cereal based food in the human. Nutr Res 2006;26:340-4.
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.
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fractional iron absorption | Iron absorption will be estimated by measuring the erythrocyte incorporation of stable (57Fe/58Fe) and radio (55Fe/59Fe) iron isotopes labels given in test meals. | 1 month after enrollment | No |
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