Absorption of Orally Ingested Phosphate in Refeeding Syndrome

NCT02880072 | Completed Phase 4

• 1 other identifier: H-6-2013-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Refeeding Syndrome; Cancer of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• plasma phosphate

  measurements up till 4 hours after oral ingestion

  4 hours

Study Arms (2)

refeeding syndrome

EXPERIMENTAL

6 patients with head and neck cancer and refeeding syndrome, 4 different of preparations of phosphate orally

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

Dietary Supplement: phosphate orally

Interventions

phosphate orally DIETARY_SUPPLEMENT

4 different preparations of phosphate

no refeeding syndrome; refeeding syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Head and Neck cancer diagnosed + informed consent

You may not qualify if:

• Severe organ failure, pregnancy, lactating women, in treatment with phosphate, unable to communicate sufficiently to understand the investigation

Sponsors & Collaborators

• Jens Rikardt Andersen: lead

Study Sites (1)

Clinic for Ear, Nose and Throat Surgery, Rigshospital

Copenhagen, 2100 Cph OE, Denmark

Location

MeSH Terms

Conditions

Refeeding Syndrome; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Jens Rikardt Andersen, MD, MPA

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, MD, MPA

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 26, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)