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

NCT01991574 | Completed Early Phase 1

• 1 other identifier: 6320
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Chronic Kidney Diseases

Keywords

urinary phosphate; iron hydroxide; hypophosphatemia; phosphate binder; ferric hydroxide adipate

Outcome Measures

Primary Outcomes (1)

• 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.

  9 hours

Secondary Outcomes (1)

• iron absorption

  14 days

Study Arms (3)

Methylcellulose

PLACEBO COMPARATOR

On one of the study days: ingest one methylcellulose capsule with a test meal rich in phosphate.

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.

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.

Dietary Supplement: Iron Hydroxide Adipate

Interventions

Calcium acetate DRUG

Calcium Acetate

Iron Hydroxide Adipate DIETARY_SUPPLEMENT

Iron Hydroxide Adipate

Placebo DRUG

methylcellulose capsules

Methylcellulose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (1)

MRC Human Nutrition Research

Cambridge, Cambridgeshire, CB1 9NL, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypophosphatemia

Interventions

calcium acetate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jonathan Powell, PhD

  Medical Research Council

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: April 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 6, 2017

Record last verified: 2017-02

Locations

GB (1)