Absorption of Orally Ingested Phosphate in Refeeding Syndrome
Primary Purpose
Refeeding Syndrome, Cancer of the Head and Neck
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
phosphate orally
Sponsored by
About this trial
This is an interventional treatment trial for Refeeding Syndrome
Eligibility Criteria
Inclusion Criteria:
- Head and Neck cancer diagnosed + informed consent
Exclusion Criteria:
- Severe organ failure, pregnancy, lactating women, in treatment with phosphate, unable to communicate sufficiently to understand the investigation
Sites / Locations
- Clinic for Ear, Nose and Throat Surgery, Rigshospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
refeeding syndrome
no refeeding syndrome
Arm Description
6 patients with head and neck cancer and refeeding syndrome, 4 different of preparations of phosphate orally
6 patients with head and neck cancer without refeeding syndrome, 4 different of preparations of phosphate orally
Outcomes
Primary Outcome Measures
plasma phosphate
measurements up till 4 hours after oral ingestion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02880072
Brief Title
Absorption of Orally Ingested Phosphate in Refeeding Syndrome
Official Title
Absorption of Orally Ingested Phosphate in Head and Neck Cancer Patients With and Without Refeeding Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Rikardt Andersen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A phosphate supplement is part of the treatment of patients with the refeeding syndrome (RFS). It is not known, if the generalized edema also affects the intestine to decrease absorption. The aim was to investigate, if oral treatment is possible in mild to moderate RFS. In a randomized crossover design 12 hospitalized head-neck cancer patients ingested four oral solutions of phosphate in two-day periods. In a low-dose period the investigators compared five mmol phosphate from either skimmed milk or Di-sodiumphosphate-di-hydrate and potassium di-hydrogens-phosphate with black currant flavor (PBC), and in a high-dose period 20 mmol from either Addiphos® or the PBC-solution. P-phosphate was measured two and four hours after the ingestion, the urinary excretion after four hours.
P-phosphate significantly increased after PBC in both the low- and high-dose and Addiphos®, but not after skimmed milk. The increase was larger after Addiphos® than the PBC-solution. There was no difference in the increase between the patients with low p-phosphate and those with normal values, and no correlation between baseline p-phosphate and percent increase. There was no group difference in the urinary excretion of phosphate. The investigators conclude that phosphate can be readily absorbed after oral administration, but skimmed milk can´t be recommend for this purpose.
Detailed Description
The study was designed as a non-blinded, randomized, controlled crossover intervention study.
A total of 12 hospitalized adult head-neck cancer patients, 11 men and one woman, gave informed consent to participate. Six patients with a p-phosphate between 0.30-0.80 mmol/l were included as well as six patients (controls) with a p-phosphate in the normal range of 0.80-1.50 mmol/l. The control patients matched the hypophosphatemic patients regarding sex, age (± 10 years) and alcohol habits. Patients with diagnosed renal failure, edema, diabetes, liver failure, gastrointestinal disorders, pregnant and lactating women were excluded. None of the patients had phosphate supplementation within the previous 24 h. Randomization determined the order of the phosphate supplements divided into low-doses of five mmol followed by high-dose 20 mmol both for two day periods. Accordingly, four days intervention with a different phosphate supplement every day.
In the low-dose period supplements consisted of a daily dose of five mmol phosphate from skimmed milk (97 mg phosphorus and 0.1 g fat/100 ml) or Phosphate with black currant flavor (PBC) (disodiumphosphatedihydrate and potassiumdihydrogenphosphate, 1 mmol phosphate/ml). In the high-dose period supplements consisted of 20 mmol phosphate from Addiphos® (Fresenius-Kabi) (disodiumphosphate, potassiumdihydrogenphosphate, potassiumhydroxide, 2 mmol/ml) and PBC. The patients fasted six hours prior to baseline blood- and urine samples and during the four hours of the trial. Blood samples were repeated after two and four hours, urine after four hours. The interval between blood samples was determined on the basis of an animal experiment, which described phosphate absorption measured in plasma 1 hour after administration (10). The interval was extended to 2 hours due to the risk of gastric retention.
The primary outcome was the changes in p-phosphate. The secondary outcomes were changes in u-phosphate and changes in p-potassium, p-magnesium and p-sodium. The paired data were tested by the Wilcoxon test. Non paired data were tested by the Mann-Whitney test. Spearman-rank correlation test was used, and the statistical analyses were performed with STATA version 13.1 (StataCorp LP, USA, Texas).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refeeding Syndrome, Cancer of the Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
refeeding syndrome
Arm Type
Experimental
Arm Description
6 patients with head and neck cancer and refeeding syndrome, 4 different of preparations of phosphate orally
Arm Title
no refeeding syndrome
Arm Type
Experimental
Arm Description
6 patients with head and neck cancer without refeeding syndrome, 4 different of preparations of phosphate orally
Intervention Type
Dietary Supplement
Intervention Name(s)
phosphate orally
Intervention Description
4 different preparations of phosphate
Primary Outcome Measure Information:
Title
plasma phosphate
Description
measurements up till 4 hours after oral ingestion
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Head and Neck cancer diagnosed + informed consent
Exclusion Criteria:
Severe organ failure, pregnancy, lactating women, in treatment with phosphate, unable to communicate sufficiently to understand the investigation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Rikardt Andersen, MD, MPA
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Ear, Nose and Throat Surgery, Rigshospital
City
Copenhagen
ZIP/Postal Code
2100 Cph OE
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Absorption of Orally Ingested Phosphate in Refeeding Syndrome
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