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Method development to study the bioequivalence of provitamin A: a pilot study in Dutch adults aged 18-35 years.

Method development to study the bioequivalence of provitamin A: a pilot study in Dutch adults aged 18-35 years. - The CARRET pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49957
Enrollment
16
Registered
2020-10-12
Start date
2020-10-25
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vitamine A deficientie Vitamin A deficiency

Interventions

Subjects will be randomly allocated to four treatment groups of equal size (n=4
group A*D). All subjects will be provided with a standardised meal on the evening before start of the study which they will consume at home between 18h00 and 20h00. They will additionally be asked t
group B, 300 µg
group C, 500 µg
and group D, 800 µg. Additional fasting blood samples will be collected at day 7, day 14, day 21 and day 28 (end point). Subjects will be asked not to deviate from their habitual diets during the s

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Female Dutch spoken Age: 18-35 years BMI: 18.5-25 kg/m2 Non-smoking

Exclusion criteria

Exclusion criteria: Pregnant or lactating Metabolic disease (e.g. Diabetes Mellitus, hypercholesterolemia) Disorder or use of drugs that interferes with fat-soluble vitamin absorption History of chronic diseases (e.g. cancer, renal disease, liver disease, gastrointestinal disorders) Food allergies related to food that will be provided during the study Recent (past 6 months) surgery, blood transfusion and blood donation Dieting or having irregular dietary habits Use of (multi)vitamin preparations with vitamin A or beta-carotene (

Design outcomes

Primary

MeasureTime frame
Percentage of 13C10-labelled retinol in plasma with intakes of varying doses of unlabelled retinol over time (4 weeks), and the shape of the dose response curve. In addition, we will measure the area under the curve (AUC) of 13C10-labelled *-carotene and 13C5-labelled retinol in blood plasma over a 24h period.

Secondary

MeasureTime frame
- Serum retinol concentration (µmol / L) - *-carotene bioconversion (%) - Inflammatory markers (C-reactive protein (CRP), alpha-glycoprotein (AGP) - Dietary energy and vitamin A intake - Genetic variants in the bco1 gene

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)