Refeeding SyndromePhase 4NCT02880072
Absorption of Orally Ingested Phosphate in Refeeding Syndrome
A Phase 4 study testing phosphate orally in people with Refeeding Syndrome and Cancer of the Head and Neck, run by Jens Rikardt Andersen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refeeding Syndrome, Cancer of the Head and Neck
- What is being tested?
- phosphate orally
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Dec 2014
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head and Neck cancer diagnosed + informed consent
Who cannot join
- Severe organ failure, pregnancy, lactating women, in treatment with phosphate, unable to communicate sufficiently to understand the investigation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Clinic for Ear, Nose and Throat Surgery, Rigshospital
Copenhagen, 2100 Cph OE
About this study
Official title: Absorption of Orally Ingested Phosphate in Head and Neck Cancer Patients With and Without Refeeding Syndrome
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.
Read the 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).
- Conditions
- Refeeding Syndrome, Cancer of the Head and Neck
- Being tested
- phosphate orally
- Medical subject headings
- Refeeding Syndrome, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phosphate orallyDietary supplement
4 different preparations of phosphate
| Study group | Role | What they receive |
|---|---|---|
| refeeding syndrome | Experimental | 6 patients with head and neck cancer and refeeding syndrome, 4 different of preparations of phosphate orally Receives: Dietary Supplement: phosphate orally |
| no refeeding syndrome | Experimental | 6 patients with head and neck cancer without refeeding syndrome, 4 different of preparations of phosphate orally Receives: Dietary Supplement: phosphate orally |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma phosphate
measurements up till 4 hours after oral ingestion
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refeeding SyndromeStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens Rikardt Andersen, MD, MPA, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880072
- Sponsor's protocol ID
- H-6-2013-001
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption of Orally Ingested Phosphate in Head and Neck Cancer Patients With and Without Refeeding Syndrome
- ClinicalTrials.gov ID
- NCT02880072
- Acronym / sponsor ID
- H-6-2013-001
- Conditions
- Refeeding Syndrome, Cancer of the Head and Neck
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Aug 2016 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| refeeding syndrome | Experimental | Dietary Supplement: phosphate orally6 patients with head and neck cancer and refeeding syndrome, 4 different of preparations of phosphate orally |
| no refeeding syndrome | Experimental | Dietary Supplement: phosphate orally6 patients with head and neck cancer without refeeding syndrome, 4 different of preparations of phosphate orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Head and Neck cancer diagnosed + informed consent
Key exclusion criteria (1 listed)
- Severe organ failure, pregnancy, lactating women, in treatment with phosphate, unable to communicate sufficiently to understand the investigation
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 |
|---|---|---|
| phosphate orally4 different preparations of phosphate | Dietary supplement | no refeeding syndrome, refeeding syndrome |
Primary outcome
plasma phosphate
Time frame: 4 hours
measurements up till 4 hours after oral ingestion
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 26 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Refeeding Syndrome
Not yet recruitingObservational study
Respiratory Quotient and Phosphate Changes During Early Critical Illness
Refeeding Syndrome, Critical Illness
Not yet recruitingObservational study
3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study
Anorexia in Adolescence, Anorexia Nervosa
Not yet recruitingObservational study
Gastrointestinal Hormones and Metabolomic Profiling Following Mixed-Meal Tolerance Tests in Patients at Risk of Refeeding Syndrome
Refeeding Syndrome, Malnutrition
Active, not recruitingPhase 1
Slow Introduction of Nutrition for Ill Malnourished Children
Malnutrition, Severe Acute, Malnutrition, Child
Recruiting
Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Critical Illness, Malnutrition
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.
Jens Rikardt Andersen, MD, MPA principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing phosphate orally in people with Refeeding Syndrome and Cancer of the Head and Neck, run by Jens Rikardt Andersen at 1 site in Denmark.
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 1 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 26 Aug 2016. 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 Denmark. 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. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
plasma phosphate (time frame: 4 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 26 Aug 2016.