Refeeding SyndromeNCT01845922
The Effect of a Diet Based on Low Sodium and Slowly Absorbed Carbohydrates on the Incidence of Refeeding Syndrome in Patients With Head and Neck Cancer
A study testing Low sodium diet in people with Refeeding Syndrome, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The study is based on a master thesis which showed that 72% of patients with head and neck cancer admitted to a Danish hospital (Rigshospitalet, Copenhagen) developed refeeding syndrome after admission. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refeeding Syndrome
- What is being tested?
- Low sodium diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to Feb 2014
- Phase
- Interventional
- 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
- authoritative
- written consent
- suspected of or diagnosed with head and neck cancer
- Increased risk of Refeeding syndrome, defined by one of the below:
- A-score of 1 in the Nutritional Risk Screening 2002 (NRS 2002)
- high levels of alcohol consumption (men>168g alcohol/week corresponding to approximately 14 units, women>84g alcohol/week corresponding to approximately 7 units)
Show all 9Show fewer
- anamnesis with prior radiation therapy
- Head and neck pain that require pain management or inhibits food intake
- the presence of problems with eating that are so serious that the food intake is inhibited
Who cannot join
- minor or declared incapable of managing own affairs
- patients that are incapable of understanding and communicating in Danish
- patients with dementia
- if the patient is not diagnosed with head and neck cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevention of Refeeding Syndrome by a Diet Regime in Patient With Head and Neck Cancer
The study is based on a master thesis which showed that 72% of patients with head and neck cancer admitted to a Danish hospital (Rigshospitalet, Copenhagen) developed refeeding syndrome after admission.
Refeeding syndrome is characterized by a decrease in plasma phosphate levels, which develops after the reintroduction of an adequate food intake after a longer period of starvation or semi-starvation. This normally happens within 7 days after reintroduction of food.
The aim of this study is to minimize the incidence of refeeding syndrome in this group of patients by reintroducing food slowly and by providing a diet low in sodium and high in slowly absorbed carbohydrates as a prevention diet (i.e. given before a potential decrease in plasma phosphate levels appear). Both patients that eat normally, patients with eating tubes and patients with central vein catheters are included in the study, but the data will be evaluated both together and separately.
Read the detailed description
A large weight loss as a result of a longer period (>30 days) of starvation or semi-starvation will result in a metabolic adaptation to the decreased food intake. To prevent the degradation of muscle mass into gluco- and ketogenic amino acids to be used for energy production, a shift from gluconeogenesis to lipolysis occurs. Lipids therefore become the primary energy fuel, and the body adapts to use ketone bodies instead of glucose. The reduction in glucose metabolism results in a decreased need for amino acids for use in gluconeogenesis. This means that less amino acids are needed for gluconeogenesis and therefore important muscle mass is preserved. At the same time as the lipid stores are degraded, an intracellular depletion of phosphate, potassium and magnesium occurs. The serum levels of these electrolytes stay within the normal range as long as the body is in the adaptive starvation state. A too quick reintroduction of food to the body will result in a major glucose-induced increase in insulin secretion that will stimulate the transport of glucose, phosphate, potassium and magnesium from plasma into the cells. Because the extracellular blood volume is much smaller than the intracellular, an influx of these electrolytes to the intracellular space will result in a quick and large decrease in the plasma levels. Likewise, an influx of glucose means that it again can enter the glucolysis, and the need for phosphate and the co-factor thiamine, for the production of ATP, will increase. The increased production of adenosine triphosphate (ATP) will activate membrane pumps and reestablish the membrane potential. This means that sodium will be transported from the large intracellular space to the small extracellular, with subsequent fluid retention and edema formation.
Therefore a slowly introduced diet low in sodium and high in slowly absorbed carbohydrates might prevent the development of refeeding syndrome.
- Conditions
- Refeeding Syndrome
- Being tested
- Low sodium diet
- Keywords
- Refeeding Syndrome, low sodium, slowly absorbed carbohydrates, hypopotassemia, hypophosphatemia
- Medical subject headings
- Refeeding Syndrome, Hypokalemia, Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low sodium dietDietary supplement
Low sodium diet
| Study group | Role | What they receive |
|---|---|---|
| Low sodium diet | Experimental | Low sodium diet Receives: Dietary Supplement: Low sodium diet |
| Control | No intervention | Standard diet regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Refeeding events
Measured by a decrease in plasma phosphate levels.
Measured: daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7
Secondary outcomes (4)
Incidence of infections
Measured by infection events recorded in the medical journal.
Measured: daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7
Length of stay
Measured by number of days in the hospital
Measured: Number of days from admission until discharge from the hospital, assessed up to 6 month
Amount of days admitted to a Intensive-care unit
Measured by number of days in the intensive-care unit
Measured: Number of days from admission until discharge from the Intensive-care unit, assessed up to 6 month
Other complications than infections
Measured by thrombosis events and other complications recorded in the medical journal
Measured: daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
- Study completionFeb 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.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Jens R. Andersen, MD, lektor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845922
- Sponsor's protocol ID
- HKM refeeding
- Status last verified
- Nov 2019
- First submitted
- 22 Apr 2013
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevention of Refeeding Syndrome by a Diet Regime in Patient With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01845922
- Acronym / sponsor ID
- HKM refeeding
- Conditions
- Refeeding Syndrome
- Keywords
- Refeeding Syndrome, low sodium, slowly absorbed carbohydrates, hypopotassemia, hypophosphatemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 May 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.
The study is based on a master thesis which showed that 72% of patients with head and neck cancer admitted to a Danish hospital (Rigshospitalet, Copenhagen) developed refeeding syndrome after admission.
Refeeding syndrome is characterized by a decrease in plasma phosphate levels, which develops after the reintroduction of an adequate food intake after a longer period of starvation or semi-starvation. This normally happens within 7 days after reintroduction of food.
The aim of this study is to minimize the incidence of refeeding syndrome in this group of patients by reintroducing food slowly and by providing a diet low in sodium and high in slowly absorbed carbohydrates as a prevention diet (i.e. given before a potential decrease in plasma phosphate levels appear). Both patients that eat normally, patients with eating tubes and patients with central vein catheters are included in the study, but the data will be evaluated both together and separately.
Detailed description
A large weight loss as a result of a longer period (>30 days) of starvation or semi-starvation will result in a metabolic adaptation to the decreased food intake. To prevent the degradation of muscle mass into gluco- and ketogenic amino acids to be used for energy production, a shift from gluconeogenesis to lipolysis occurs. Lipids therefore become the primary energy fuel, and the body adapts to use ketone bodies instead of glucose. The reduction in glucose metabolism results in a decreased need for amino acids for use in gluconeogenesis. This means that less amino acids are needed for gluconeogenesis and therefore important muscle mass is preserved. At the same time as the lipid stores are degraded, an intracellular depletion of phosphate, potassium and magnesium occurs. The serum levels of these electrolytes stay within the normal range as long as the body is in the adaptive starvation state. A too quick reintroduction of food to the body will result in a major glucose-induced increase in insulin secretion that will stimulate the transport of glucose, phosphate, potassium and magnesium from plasma into the cells. Because the extracellular blood volume is much smaller than the intracellular, an influx of these electrolytes to the intracellular space will result in a quick and large decrease in the plasma levels. Likewise, an influx of glucose means that it again can enter the glucolysis, and the need for phosphate and the co-factor thiamine, for the production of ATP, will increase. The increased production of adenosine triphosphate (ATP) will activate membrane pumps and reestablish the membrane potential. This means that sodium will be transported from the large intracellular space to the small extracellular, with subsequent fluid retention and edema formation.
Therefore a slowly introduced diet low in sodium and high in slowly absorbed carbohydrates might prevent the development of refeeding syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low sodium diet | Experimental | Dietary Supplement: Low sodium dietLow sodium diet |
| Control | No intervention | –Standard diet regime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- authoritative
- written consent
- suspected of or diagnosed with head and neck cancer
- Increased risk of Refeeding syndrome, defined by one of the below:
- A-score of 1 in the Nutritional Risk Screening 2002 (NRS 2002)
Key exclusion criteria (4 listed)
- minor or declared incapable of managing own affairs
- patients that are incapable of understanding and communicating in Danish
- patients with dementia
- if the patient is not diagnosed with head and neck cancer
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 |
|---|---|---|
| Low sodium dietLow sodium diet | Dietary supplement | Low sodium diet |
Primary outcome
Occurence of Refeeding events
Time frame: daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7
Measured by a decrease in plasma phosphate levels.
4 secondary outcomes
Incidence of infections
Time frame: daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7
Length of stay
Time frame: Number of days from admission until discharge from the hospital, assessed up to 6 month
Amount of days admitted to a Intensive-care unit
Time frame: Number of days from admission until discharge from the Intensive-care unit, assessed up to 6 month
Other complications than infections
Time frame: daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7
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 13 Nov 2019.
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 R. Andersen, MD, lektor 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 study testing Low sodium diet in people with Refeeding Syndrome, run by University of Copenhagen 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 9 inclusion and 4 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 13 Nov 2019. 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.
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?
Occurence of Refeeding events (time frame: daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7). 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 13 Nov 2019.