Clinical trial NCT02585661: Iron Bioavailability From Dairy Product
Official title: Iron Bioavailability From Fortified Dairy Product in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-10-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds

Detailed description: This single center trial will be double-blind, controlled randomized with a crossover trial. One group (n=10) will start the study with the consumption of a Fe-54 salt fortified dairy product, while the other group will start the study with the consumption of Fe-57 salt fortified dairy product. The day after, in a cross over design, subjects will be administered the alternative test product. A blood sampling will be performed 14 days after the last stable isotope administration to allow the measurement of Fe stable isotope ratios and the calculation of Fe absorption. The duration of the trial will be 16 days in total.

The total sample size is 20 enrolled subjects. Patients will be healthy females aged 18-40 years old

Eligibility criteria: Inclusion Criteria:

* Women aged 18-40 years old,
* Healthy, based on the medical screening visit including a blood formula and biochemistry,
* Normal BMI for age (18.5-25.0),
* Weight less than 65 kg,
* Having obtained informed consent prior trial entry.

Exclusion Criteria:

* Anemia or polycythemia respectively evidenced,
* Significant blood losses over the past 6 months,
* Plasma ferritin out of 8-50 ug/L range.
* Any infectious and inflammatory disease in the past four weeks,
* Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease,
* Known food allergy,
* Pregnancy (anamnesis) and/or lactation,
* History of cancer within the past year,
* Significant weight loss during the last 3 months (5% and more),
* medication or supplement which may impact red cells count, Hb or Ht
* Fe supplementation or perfusion in the last three months,
* Smokers (\>5 cigarettes),
* Have a high alcohol consumption (more than 2 drinks/day),
* Consumption of illicit drugs anamnesis only,
* Subject having a hierarchical link with the Investigator or co-investigators,
* Subject who cannot be expected to comply with treatment or study procedure,
* participating or having participated in another clinical trial during the past month prior to the beginning of this study.

Primary outcomes:
measure: Change from baseline in the isotopic ratio of iron in blood at week 2
timeFrame: 14 days after the last stable isotope administration
Secondary outcomes:
measure: Measurement of plasma ferritin as biomarker of Fe status
timeFrame: On the 1st day of the stable isotope administration
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Metabolic Unit, Clinical Development Unit, Nestec
Study officials:
affiliation: Metabolic Unit - Nestec
name: Maurice Beaumont
role: PRINCIPAL_INVESTIGATOR
References: