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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|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|
Placebo Comparator: Methylcellulose
On one of the study days: ingest one methylcellulose capsule with a test meal rich in phosphate.
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
- 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.
- 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.
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
|MRC Human Nutrition Research|
|Cambridge, Cambridgeshire, United Kingdom, CB1 9NL|
|Study Chair:||Jonathan Powell, PhD||Medical Research Council|