Iron Bioavailability From Dairy Product
Iron Bioavailability From Fortified Dairy Product in Healthy Women
1 other identifier
interventional
20
1 country
1
Brief Summary
Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy-volunteers
Started Oct 2015
Shorter than P25 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 16, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 12, 2016
October 1, 2015
2 months
October 16, 2015
January 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in the isotopic ratio of iron in blood at week 2
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes
14 days after the last stable isotope administration
Secondary Outcomes (1)
Measurement of plasma ferritin as biomarker of Fe status
On the 1st day of the stable isotope administration
Study Arms (2)
Dairy product + Salt 1
ACTIVE COMPARATORDairy product fortified with enriched Fe-54 salt (1)
Dairy product + Salt 2
EXPERIMENTALDairy product fortified with enriched Fe-57 salt (2)
Interventions
2.5mg of Fe per 100g of product
2.5mg of Fe per 100g of product
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Metabolic Unit, Clinical Development Unit, Nestec
Lausanne, 1000, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Maurice Beaumont
Metabolic Unit - Nestec
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2015
First Posted
October 23, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 12, 2016
Record last verified: 2015-10