Iron & Alginate Study
Condition: Iron Deficiency; Anaemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Iron deficiency anaemia affects around two billion people worldwide. Food fortification with
      iron is a realistic way to combat this problem. Water soluble forms of iron are considered to
      be more bioavailable than nonsoluble iron compounds. However, the former often cause sensory
      problems when added to foods, while the latter cause fewer problems but are not generally
      well absorbed and are therefore ineffective as fortificants. A potential strategy for
      overcoming this problem is the use of water soluble iron compounds protected by a water
      resistant barrier, which will prevent potential organoleptic changes within fortified foods
      and protect the iron (from oxidation) through the digestion process thus increasing its
      availability. The investigators will use alginate, in the form of alginate beads, as a
      protective barrier for soluble iron gluconate. It has been shown that alginates bind divalent
      and trivalent cations and therefore may be a useful vehicle for soluble iron compounds to
      fortify foods.

      The aim of this project is to measure the effect of alginate on iron absorption from ferrous
      gluconate and assess the potential modulating effect of calcium on iron absorption in the
      presence and absence of alginate.
    

Detailed description: 
      This study is a randomised, single blinded, cross-over trial with participants randomly
      allocated into two groups: A (n= 8 volunteers) and B (n=8 volunteers). The study will include
      a total of four arms.

      By administration of test meals #1 (iron in alginate beads) and #4 (iron in a capsule) the
      possible protective effect of alginate on iron absorption will be investigated. By
      administration of test meal #2 (iron in alginate beads + calcium capsule)and #3 (iron in a
      capsule + calcium in a capsule)the study will investigate whether alginates can bind calcium
      (a well-known iron inhibitor) in vivo, thus diminish the potential negative effect of calcium
      on iron absorption.

      Only half (8) of the volunteers will undergo treatments including calcium. Therefore group A
      will undergo all 4 tests, whereas group B will undergo 2 out of 4 tests.

      The four test meals will be administered a week apart following an overnight fast. On each
      occasion blood sampling will take place over a period of 6h with samples taken via a cannula
      at t=0, 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Serum samples will be
      analysed for iron content allowing calculation of iron absorption.

      The assumptions made for the power calculation to estimate the number of volunteers are that
      a difference of 2.5% in iron absorption in the presence and absence of alginate ( test meal
      #1 and test meal #4) will be nutritionally significant. A minimum of 12 volunteers would be
      required to complete the study to detect a difference of 2.5% at a significance level of 0.05
      for 80% power. A minimum of 8 volunteers would be required to detect a significant difference
      in iron absorption of 3.3% between a test meal containing 20mg of iron as iron gluconate with
      calcium and a test meal containing 20mg of iron as iron gluconate with calcium and alginate
      beads (test meals #2 and #3). This assumes a power of 80%, a level of significance of 0.05
      and standard deviation of differences (within pairs) of 2.8%
    

Intervention name(s): alginate beads containing ferrous gluconate; ferrous gluconate in a capsule; ferrous gluconate in a capsule in presence of calcium; alginate beads with ferrous gluconate in presence of calcium
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate incorporated into alginate beads (approximately 22.2g)and added to cola jelly (200ml) will be given to the volunteer together with 3 placebo capsules (each containing 50mg of dextrose)and cola drink (200ml). Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.; After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate in a capsule and 2 placebo capsules (each containing 50mg of dextrose) followed by a cola jelly (200ml)and cola drink (200ml) will be given to the volunteer. Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.; After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate in a capsule together with 2 calcium capsules (each containing 300mg of calcium phosphate)followed by cola jelly (200ml) and cola drink(200ml)will be given to the volunteer . Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.; After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate incorporated into alginate beads (approximately 22.2g)and added to cola jelly (200ml) will be given to the volunteer together with 2 calcium capsules (each containing 300mg of calcium as calcium phosphate, 1 placebo capsule (containing 50mg of dextrose)and cola drink (200ml). Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.
Other intervention name(s): iron in alginate beads; iron in capsule; iron in a capsule followed by calcium phosphate; iron in alginate beads in presence of calcium phosphate
Intervention MeSH terms: Calcium, Dietary; Iron; Ferrous gluconate; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: iron; fortification; alginate; iron deficiency