Iron & Alginate Study

This study has been completed.
Sponsor:
Collaborator:
Institute of Food Research
Information provided by (Responsible Party):
University of East Anglia
ClinicalTrials.gov Identifier:
NCT01528644
First received: January 17, 2012
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Iron Deficiency
Anaemia
Dietary Supplement: alginate beads containing ferrous gluconate
Dietary Supplement: ferrous gluconate in a capsule
Dietary Supplement: ferrous gluconate in a capsule in presence of calcium
Dietary Supplement: alginate beads with ferrous gluconate in presence of calcium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Study to Measure the Absorption of Iron From Ferrous Gluconate Incorporated Into Alginate Beads.

Resource links provided by NLM:


Further study details as provided by University of East Anglia:

Primary Outcome Measures:
  • Change in iron absorption [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iron in beads
All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations.
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.
Other Name: iron in alginate beads
Experimental: Iron in capsule
All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations.
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.
Other Name: iron in capsule
Experimental: Iron in beads in presence of calcium
All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations.
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.
Other Name: iron in alginate beads in presence of calcium phosphate
Experimental: Iron in capsule in presence of calcium
All experimental days will be exactly the same with the exception of the test meal administered to the volunteer. Volunteers will undergo a 10 hour overnight fast from 10:00pm, then they will be asked to attend the CRTU at approximately 8:00 am the following morning. A nurse will take and record the volunteer's blood pressure and if within the range an intravenous (i.v.) cannula will be inserted into a vein in one of the volunteer's arms. The cannula will remain in situ for six hours. After the first blood sample (t=0) will be taken, volunteers will consume one out of 4 test meals. After consumption further blood samples will be collected at: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Blood samples will subsequently be analysed for serum iron concentrations.
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.
Other Name: iron in a capsule followed by calcium phosphate

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%

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528644

Locations
United Kingdom
Clinical Research and Trials Unit (CRTU)/ Norfolk and Norwich University Hospital (NNUH)
Norwich, Norfolk, United Kingdom, NR4 7TJ
Sponsors and Collaborators
University of East Anglia
Institute of Food Research
Investigators
Principal Investigator: Susan Fairweather-Tait, Professor University of East Anglia
  More Information

No publications provided

Responsible Party: University of East Anglia
ClinicalTrials.gov Identifier: NCT01528644     History of Changes
Other Study ID Numbers: BBSRC grant:BB/G0055833/1, 2011/2012-05
Study First Received: January 17, 2012
Last Updated: February 28, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of East Anglia:
iron
fortification
alginate
iron deficiency

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Alginic acid
Ferrous gluconate
Calcium, Dietary
Iron
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Hematinics
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 26, 2014