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Completed

NCT Number: NCT02585661

Iron Bioavailability From Dairy Product

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Metabolic Unit, Clinical Development Unit, Nestec

Lausanne, 1000, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dairy product fortified with enriched Fe-54 salt (1)

Dietary Supplement

2.5mg of Fe per 100g of product

Dairy product fortified with enriched Fe-57 salt (2)

Dietary Supplement

2.5mg of Fe per 100g of product

Primary outcomes

  1. Change from baseline in the isotopic ratio of iron in blood at week 2

    Time frame: 14 days after the last stable isotope administration

    The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes

Secondary outcomes

  1. Measurement of plasma ferritin as biomarker of Fe status

    Time frame: On the 1st day of the stable isotope administration

    The plasma ferritin will be measured before the administration of test meal including iron isotopes

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Iron Bioavailability From Fortified Dairy Product in Healthy Women

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 23, 2015
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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