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

February 3, 2017 updated by: dora pereira, Medical Research Council

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB1 9NL
        • MRC Human Nutrition Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council

Investigators

  • Study Chair: Jonathan Powell, PhD, Medical Research Council

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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