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Development of method to predict vitamin A equivalency

Development of method to predict the vitamin A equivalency of supplemental preformed vitamin A: feasibility pilot study - Development of method to predict vitamin A equivalency

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57715
Enrollment
6
Registered
2024-08-23
Start date
2025-02-09
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Vitamin A deficiency Vitamin A deficiency

Interventions

At day 0, a dose of 6 µmol (~2 mg) 13C10-retinyl acetate will be administrated&nbsp
orally by means of a capsule filled with oil. Unlabelled vitamin A supplements&nbsp
(3 mg/d) will be consumed by subjects from day 60 till 80 to prompt a decrease&nbsp
in plasma retinol specific activity.

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: FemaleAge: 18-45 yearsNon-smokingWilling to consume VA supplements for 21 days

Exclusion criteria

Exclusion criteria: A potential subject will be excluded from the study due to:Pregnancy or lactating (Pregnancy test (urine hCG) =72 hours before start Day 60; when in doubt, serum hCG confirmation).Self-reported history of metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseasesReduced kidney function (glomerular filtration rate  <90ml /min per 1.73 m2)Reduced liver function (alkaline phosphatases (> 240 IU/L), AST (> 40 IU/L), ALT (> 40 IU/L) and gamma glutamyl transferase (> 50 IU/L))Self-reported hypercholesterolemiaContinuous/long term use of medication during whole studies (except for contraception)Disorder or use of drugs that interferes with fat-soluble vitamin absorption Blood transfusion, recent major surgery, blood donation (< 6 months ago) Use of (multi)vitamin preparations with VA or ß-carotene up till 3 months before the start of the studyDieting or having irregular dietary habitsNot willing or afraid of having blood drawn Participation in another clinical trial

Design outcomes

Primary

MeasureTime frame
The primary study parameters will be specific activity (SAp), fraction of the administered isotope dose circulating in plasma (FDSAp), plasma retinol concentrations and total body stores (TBS).

Secondary

MeasureTime frame
The secondary study parameters will be inflammatory marker (C-reactive protein (CRP), and dietary energy and vitamin A intake.

Countries

Netherlands

Contacts

Public ContactT.L Chimhashu

Wageningen Universiteit

tsitsi.chimhashu@wur.nl+31638357481

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 3, 2026