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Clinical Data

Effects of a 250-mL enema containing sodium phosphate on electrolyte concentrations in healthy volunteers: An open-label, randomized, controlled, two-period, crossover clinical trial.


MD, PhD Belen Sedaba MD, PhD Josh R. Azanza, PharmD Miguel A. Campanero, MD, PhD Emilio Garcia-Quetglas, PhD Maria Josh Munoz and PhD Santiago Marco.

 

Clinical Pharmacology Service, University Hospital of Navarra, School of Medicine, Pamplona, Spain Lab oratorios Casen Fleet S.L., Zaragoza, Spain.

 


Abstract

 

Background:

 

Enemas are used by individuals with constipation and are often required before certain medical diagnostic procedures and surgical interventions. However, abnormalities in serum electrolyte concentrations have been associated with enema use.

 

Objective:

 

The aim of this study was to determine the changes in serum electrolyte concentrations (phosphorus, calcium, sodium, and potassium) and urinary phosphorus elimination after the administration of a sodium phosphate enema.

 

Methods:

 

Healthy volunteers aged 35 to 70 years were eligible for this open-label, randomized, controlled, 2-period, crossover clinical trial at the Clinical Research Unit of the University Hospital of Navarra, Pamplona, Spain. The study comprised 2 one-day periods separated by a 7-day washout. All subjects were randomly assigned in a 1:1 ratio to 1 of 2 study sequences: (1) a single dose of Enema Casen® 250 mL in the first period followed by no treatment (control) in the second period, or (2) no treatment in the first period followed by a single dose of the study drug in the second period. The sequence of treatment was assigned using a randomization table that was prepared before the beginning of the study. Serum concentrations of phosphorus, sodium, potassium, and calcium were measured in both periods.Urinary phosphorus elimination was measured for 12 hours after enema administration (Ae 0-12) in a subset of the subjects in the second period. Adverse events (AEs) were monitored by the investigators throughout the study. Normal ranges for the electrolytes were as follows: phosphorus, 2.5 to 5 mg/dL; calcium, 8.5 to 10.5 mg/dL; sodium, 135 to 145 mEq/L; and potassium, 3.5 to 5 mEq/L.

 

Results:

 

Twenty-four subjects (12 men, 12 women; mean [SD] age, 47.8 [9.6] years [range, 36–68 years]) participated in the study. All of the subjects were white and none were smokers. Twelve hours after enema administration, mean serum phosphorus and sodium concentrations increased by a mean of 1.18 mg/dL and 1.32 mEq/L, respectively (both, P < 0.001). Mean serum phosphorus concentrations were above the upper limit of normal (5 mg/dL) at 30 and 60 minutes after enema administration. In all subjects the values returned to normal within 4 hours after enema administration; a meal was provided after a 3-hour fast. Four subjects (16.7%) had ≥1 serum phosphorus concentration measurement ≥7 mg/dL, a value that is considered serious hyperphosphatemia. retention time (r2 = 0.452; P < 0.001). No abnormal serum concentrations were obtained for the other electrolytes measured. Phosphorus Ae0–12 was increased after enema administration by 86% (P < 0.001). No serious AEs were observed, although 13 AEs were reported in 9 subjects. None of the changes in serum electrolyte concentrations were associated with clinical symptoms.

 

Conclusions:

 

Administration of an enema containing 250 mL of sodium phosphate was associated with serum phosphorus concentrations of ≥7 mg/dL in 16.7% of the healthy subjects who participated in the study; however, none of those subjects experienced hypocalcemia. Enema retention time was significantly correlated with the degree of phosphatemia.

 

Key words: phosphatemia; electrolyte modifications; sodium phosphate enema; phosphaturia; absorption.

 

This study was presented in part as an abstract at the XIXth Spanish Clinical Pharmacology Society (Sociedad Española de Farmacología Clínica-SEFC), October 27-30, 2004, Santander, Spain.