HealthyEarly Phase 1NCT01991574
Effect of the Consumption of Ferric Hydroxide Adipate on Urinary Phosphorus Excretion.
A Early Phase 1 study testing Calcium acetate and Iron Hydroxide Adipate in people with Healthy and Chronic Kidney Diseases, run by Medical Research Council at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Chronic Kidney Diseases
- What is being tested?
- Calcium acetate and Iron Hydroxide Adipate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Oct 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females, aged >18 years, who are generally healthy.
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
MRC Human Nutrition Research
Cambridge, Cambridgeshire, CB1 9NL
About this study
Official title: 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.
- Conditions
- Healthy, Chronic Kidney Diseases
- Being tested
- Calcium acetate, Iron Hydroxide Adipate, Placebo
- Keywords
- urinary phosphate, iron hydroxide, hypophosphatemia, phosphate binder, ferric hydroxide adipate
- Medical subject headings
- Renal Insufficiency, Chronic, Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium acetateDrug
Iron Hydroxide AdipateDietary supplement
PlaceboDrug
methylcellulose capsules
| Study group | Role | What they receive |
|---|---|---|
| Methylcellulose | Placebo comparator | On one of the study days: ingest one methylcellulose capsule with a test meal rich in phosphate. Receives: Drug: Placebo |
| Calcium Acetate | Active comparator | On one of the study days: ingest 667 mg calcium acetate, equivalent to 169 mg elemental calcium, with a test meal rich in phosphate. Receives: Drug: Calcium acetate |
| Iron Hydroxide Adipate | Experimental | 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. Receives: Dietary Supplement: Iron Hydroxide Adipate |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary phosphate
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.
Measured: 9 hours
Secondary outcomes (1)
iron absorption
iron absorption from the ferric hydroxide adipate treatment will be determined by labelling this preparation with 58Fe and measuring day 14 erythrocyte 57Fe:58Fe.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startApr 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, dora pereira, Medical Research Council
- Investigators
- Jonathan Powell, PhD, Study chair, Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991574
- Sponsor's protocol ID
- 6320
- Status last verified
- Feb 2017
- First submitted
- 18 Nov 2013
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of the Consumption of Ferric Hydroxide Adipate on Urinary Phosphorus.
- ClinicalTrials.gov ID
- NCT01991574
- Acronym / sponsor ID
- 6320
- Conditions
- Healthy, Chronic Kidney Diseases
- Keywords
- urinary phosphate, iron hydroxide, hypophosphatemia, phosphate binder, ferric hydroxide adipate
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Apr 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methylcellulose | Placebo comparator | Drug: PlaceboOn one of the study days: ingest one methylcellulose capsule with a test meal rich in phosphate. |
| Calcium Acetate | Active comparator | Drug: Calcium acetateOn one of the study days: ingest 667 mg calcium acetate, equivalent to 169 mg elemental calcium, with a test meal rich in phosphate. |
| Iron Hydroxide Adipate | Experimental | Dietary Supplement: Iron Hydroxide AdipateOn one of the study days: ingest 800 mg ferric hydroxide adipate, equivalent to 175 mg elemental iron, with a test meal rich in phosphate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males and females, aged >18 years, who are generally healthy.
Key exclusion criteria (21 listed)
- Pregnancy and lactation
- iron deficiency and iron deficiency anaemia
- weight change of +/-2kg in the past month
- dysphagia
- surgery in the past three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium acetate | Drug | Calcium Acetate |
| Iron Hydroxide Adipate | Dietary supplement | Iron Hydroxide Adipate |
| Placebomethylcellulose capsules | Drug | Methylcellulose |
Primary outcome
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.
1 secondary outcome
iron absorption
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Powell, PhD study chair
Medical Research Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Calcium acetate and Iron Hydroxide Adipate in people with Healthy and Chronic Kidney Diseases, run by Medical Research Council at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary phosphate (time frame: 9 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.