NCT01528644

Iron & Alginate Study

Study to Measure the Absorption of Iron From Ferrous Gluconate Incorporated Into Alginate Beads.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of East Anglia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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%

Conditions

• Iron Deficiency
• Anaemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	alginate beads containing ferrous gluconate	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.
DIETARY_SUPPLEMENT	ferrous gluconate in a capsule	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.
DIETARY_SUPPLEMENT	ferrous gluconate in a capsule in presence of calcium	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.
DIETARY_SUPPLEMENT	alginate beads with ferrous gluconate in presence of calcium	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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-11-01
• Completion: 2013-01-01
• First posted: 2012-02-08
• Last updated: 2013-03-01

Locations

1 site across 1 country: United Kingdom