Iron Deficiency Clinical Trial
Official title:
Study to Measure the Absorption of Iron From Ferrous Gluconate Incorporated Into Alginate Beads.
Verified date | February 2013 |
Source | University of East Anglia |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | January 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Apparently healthy women (aged 18-45) or male blood donors (aged 18-65) - Serum ferritin value of =15 = 60µg/L - BMI >18.5 or < 30 - Willingness to consume jelly prepared with the use of gelatine from an animal source. Exclusion Criteria: - Diagnosed with a long-term illness requiring active treatment, e.g. diabetes, cancer, cardiovascular disease - Currently smoking or stopped smoking in the last 12 months - Previous or current GI disease - Any significant co-morbidity - Previous GI surgery - Blood donation within the previous 3 months assuming that volume taken is above 500ml in a 4-month period - Blood transfusion within the last 3 months - The results of the screening tests indicate unsuitability to take part in the study - Related to someone in the study team i.e. spouse, partner or immediate family member - Regular prescribed medication that may interfere with iron metabolism - Regular use of antacids and laxatives (at least once a week) - Women who are pregnant or less than 12 months since giving birth - Women who are breast feeding - Vitamin supplements with or without minerals if taken more than once a week, and unwillingness to discontinue occasional use for the duration of study - Unwillingness to discontinue use of herbal supplements for the duration of study - Unwillingness to consume jelly prepared with animal source gelatine - Use of antibiotics within four weeks prior to study start Parallel participation in another study which involves dietary interventions or sampling of blood that may increase the volume taken above 500ml in a 4-month period - Asthma requiring treatment within the last two years - Results of clinical screening which indicate a health problem which could compromise the well-being of the volunteer if they participated or which would affect the study data. |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Clinical Research and Trials Unit (CRTU)/ Norfolk and Norwich University Hospital (NNUH) | Norwich | Norfolk |
Lead Sponsor | Collaborator |
---|---|
University of East Anglia | Institute of Food Research |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in iron absorption | Iron absorption (by measuring iron appearance in the serum)will be measured on four occasions with a week in between each measurement. Absorption will be assessed in response to four test meals as follows: unprotected ferrous gluconate, iron gluconate incorporated into alginate beads,ferrous gluconate incorporated into alginate beads given with calcium, and unprotected ferrous gluconate given with calcium. | Four weekly measurements over a period of three weeks (6h Cannulation, baseline blood sample (t=0). Test meal 1, followed by blood sample collection at 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Removal of the cannula) | No |
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