Iron Isotope Study of an Iron Fatty Acid Complex
Condition: Iron-deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The study aims at assessing the iron (Fe) bioavailability from a newly developed iron
      compound - an iron fatty acid complex. The iron from the compound is hypothesized to have a
      higher absorption rate than commonly available supplements in the market. The study is a
      cross over, human iron isotope study with three arms where participants consume the
      experimental dietary products in a randomized fashion. The study duration is of 45 days -
      from the day of the capsule administration till the last blood sampling point
    

Detailed description: 
      Iron deficiency remains a major public health concern in both industrialized and
      non-industrialized (developing) countries. Most supplements in the present day, to address
      the problem of iron deficiency, are in the form of ferrous salts, especially ferrous sulfate.
      Ferrous salts are absorbed by the non-heme iron pathway involving the Divalent Metal
      Transporter 1 (DMT-1) receptor, where the absorption rate is 20% of the total iron content.
      The common strategy of the food supplement industries is to increase the iron load in the
      supplements to provide the necessary amount of iron, compensating for the low absorption
      rate. However, these have side effects associated with the high dosage. Instead of a high
      dosage, a more effective strategy would be to incorporate the iron in a way that the
      absorption rate is maximized. The intervention product, an iron fatty acid complex (IFAC),
      containing 12 mg of iron, is expected to be absorbed as effective as any ferrous sulfate
      supplement in the market due to the alternative metabolic route that is hypothesized to be
      taken by the complex.

      The first week of the study comprises of the administration of the capsules containing the
      complexes to the participants on day 1 , day 3 and day 5 of the study respectively. Blood
      samples are collected on day 10,20, 30 and 40 and 160 days after the last day of the capsule
      administration..

      The primary objectives of this trial are:

      To assess the iron bioavailability from the developed iron salt fatty acid complexes (IFAC)
      and micro-emulsified iron fatty acid complex (MIFAC) and compare it with the bioavailability
      of the reference ferrous sulfate (FeSO4) To investigate whether the MIFAC promotes absorption
      compared to IFAC and the reference.

      Fractional iron absorption from the three intervention products will be calculated based on
      the shift of the stable iron isotope ratios in collected blood samples at 10, 20, 30, 40 and
      160 days after administration of the stable isotopically labelled capsules. Stable iron
      isotope ratios will be determined by mass spectrometry.
    

Intervention name(s): IFAC; MIFAC; Control Ferrous Sulfate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): This intervention will contain the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope 58Fe; This intervention will contain the micellarized form of the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope with 57Fe; This intervention will contain ferrous sulfate in the form of a solution labelled with the iron isotope 54Fe. A capsule with the same amount of fat as in the other arms will be administered to the participants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Iron; Isotope study; Fatty Acid