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Effect of the Consumption of Ferric Hydroxide Adipate on Urinary Phosphorus Excretion.

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ClinicalTrials.gov Identifier: NCT01991574
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
dora pereira, Medical Research Council

Brief Summary:

Ferric hydroxide adipate is a ferric iron supplement containing iron hydroxide and a dietary organic acid that was developed at MRC Human Nutrition Research. We aim to determine if the ingestion of ferric hydroxide adipate with food induces a reduction in urinary phosphate concentration, compared with the administration of placebo plus the same food on a different occasion. We hypothesise that ferric hydroxide adipate binds some phosphate ions in the gastrointestinal tract, which prevents part of the phosphate load in a meal from being absorbed. On another visit, calcium will be given with the same food, as a positive control, since this element is well known to restrict dietary phosphate absorption through the formation of insoluble calcium phosphates in the gut lumen. We will compare urinary phosphate concentrations after co-ingestion of the calcium salt and food versus urinary phosphate following ferric hydroxide adipate and the same food. Additionally, the calcium data will be compared with placebo data, since a significant reduction in urinary phosphate concentrations after calcium treatment will confirm the suitability of the study design.

Finally, iron absorption from the ferric hydroxide adipate treatment will be determined by labelling this preparation with 58Fe and measuring day 14 erythrocyte 57Fe:58Fe.

The study design is: Three-way cross-over volunteer absorption study. Volunteers will not be told which treatment they receive (placebo, ferric hydroxide adipate, or supplemental calcium). Researchers co-ordinating the study on a day to day basis will be aware of treatment allocation, but analysts will not be told which samples correspond to which treatments.


Condition or disease Intervention/treatment Phase
Healthy Chronic Kidney Diseases Drug: Calcium acetate Dietary Supplement: Iron Hydroxide Adipate Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Study of the Effect of the Consumption of Ferric Hydroxide Adipate on Urinary Phosphorus.
Study Start Date : April 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Placebo Comparator: Methylcellulose
On one of the study days: ingest one methylcellulose capsule with a test meal rich in phosphate.
Drug: Placebo
methylcellulose capsules

Active Comparator: Calcium Acetate
On one of the study days: ingest 667 mg calcium acetate, equivalent to 169 mg elemental calcium, with a test meal rich in phosphate.
Drug: Calcium acetate
Experimental: Iron Hydroxide Adipate
On one of the study days: ingest 800 mg ferric hydroxide adipate, equivalent to 175 mg elemental iron, with a test meal rich in phosphate.
Dietary Supplement: Iron Hydroxide Adipate



Primary Outcome Measures :
  1. urinary phosphate [ Time Frame: 9 hours ]
    To determine if the ingestion of ferric hydroxide adipate with food induces a reduction in urinary phosphate concentration, compared with the administration of placebo plus the same food on a different occasion.


Secondary Outcome Measures :
  1. iron absorption [ Time Frame: 14 days ]
    iron absorption from the ferric hydroxide adipate treatment will be determined by labelling this preparation with 58Fe and measuring day 14 erythrocyte 57Fe:58Fe.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Males and females, aged >18 years, who are generally healthy.

Exclusion Criteria:

  • Pregnancy and lactation
  • iron deficiency and iron deficiency anaemia
  • weight change of +/-2kg in the past month
  • dysphagia
  • surgery in the past three months
  • cancer in the last ten years
  • diabetes
  • known medical and genetic conditions interfering with calcium and phosphate metabolism: e.g. hyper/hypo-parathyroidism, Fanconi syndrome, hyper/hypothyroidism (except individuals who are taking stable doses of thyroid hormones)
  • chronic infection or chronic inflammation
  • cardiovascular disease
  • chronic respiratory disease
  • abnormal renal function (based on glomerular filtration rate)
  • known renal disease
  • abnormal liver function/known liver disease
  • hereditary haemochromatosis or haemoglobinopathies
  • gastrointestinal disease
  • bone disease
  • hypertension
  • current use of proton pump inhibitors
  • use of other medication that affects mineral homeostasis (on a case by case basis, in consultation with HNR clinician)
  • Extreme muscle hypertrophy (e.g. body building)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991574


Locations
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United Kingdom
MRC Human Nutrition Research
Cambridge, Cambridgeshire, United Kingdom, CB1 9NL
Sponsors and Collaborators
Medical Research Council
Investigators
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Study Chair: Jonathan Powell, PhD Medical Research Council

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Responsible Party: dora pereira, Dr, Medical Research Council
ClinicalTrials.gov Identifier: NCT01991574     History of Changes
Other Study ID Numbers: 6320
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Keywords provided by dora pereira, Medical Research Council:
urinary phosphate
iron hydroxide
hypophosphatemia
phosphate binder
ferric hydroxide adipate
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Calcium, Dietary
Iron
Calcium
Calcium acetate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action