To measure the effect of folic acid supplementation on heme iron absorption in vivo.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Deficientie ziekten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of incorporation of 57Fe and 58Fe in red blood cells after 14
days will be the main outcome measure.
Secondary outcome
Not applicable
Background summary
Recently, for the first time an intestinal heme transporter (HCP1) was
identified. In a later study, the same transporter was identified to be a
proton-coupled folate transporter (PCFT) with a higher affinity for folates
than for heme iron. Therefore, use of folic acid supplements may inhibit the
absorption of heme iron.
Study objective
To measure the effect of folic acid supplementation on heme iron absorption in
vivo.
Study design
The study is designed as a placebo controlled cross-over experiment.
Intervention
On two consecutive days, 4 mg of iron will be administered either as 32.4 mg of
57Fe protoporhyrin chloride or 32 mg of 58Fe protoporphyrin chloride with a
spread on a bread roll. In addition, 1 mg of folic acid or placebo will be
administered.
Study burden and risks
Participants are asked to visit the research site once for screening and four
times after inclusion. At each occasion, 5-20 mL whole blood will be collected
by venapuncture. Venapunctures occasionally lead to painful bruises which
usually disappear within one week. Participants will be asked to fill out a
questionnaire on relevant general and medical issues, and basic anthropometrics
(weight, height) will be taken. During the study, 4 mg of iron labelled with
stable isotopes (57Fe and 58Fe) will be administered orally as hemin at two
consecutive days. Stable isotopes are non-hazardous to humans. The administered
compounds will be subdued to standard toxicity procedures (purity, presence of
heavy metals). All subjects will have a check-up of their iron status. Since
included subjects will be marginally iron deficienct, participants will receive
dietary advice in order to improve their iron status after the study and will
be referred to their general practitioner on a voluntary basis.
Postbus 8129
6700 EV Wageningen
Nederland
Postbus 8129
6700 EV Wageningen
Nederland
Listed location countries
Age
Inclusion criteria
Body weight <60 kg, BMI 20-25 kg/m2, apparently healthy but marginal iron status (serum ferritin <25µg/L, Hb < 110 g/L).
Exclusion criteria
Severe anaemia or iron depletion (Hb < 70 g/L, serum ferritin < 12 µg/L). Use of drugs, unless no interference with iron/ folic acid metabolism or gastro-intestinal conditions such as paracetamol. Use of vitamin/mineral supplements containing iron or folic acid. Gastro-intestinal disorders, pregancy, lactation, unregular menstrual cycle.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL19912.081.07 |