Body Composition and Serum Biochemistry After Intravenous Infusion or Oral Intake of Saline in Healthy Volunteers
Changes in Body Composition, Hematological Parameters, and Serum Biochemistry and After Rapid Intravenous Infusion or Oral Intake of 2L of 0.9% Saline Solution in Young Healthy Volunteers. A Randomized Cross-over Study
2 other identifiers
interventional
10
1 country
1
Brief Summary
The investigators conducted a cross-over study to compare the response of healthy young volunteers to a rapid oral intake or intravenous infusion of 0.9% saline solution on the body composition, serum electrolytes, albumin, and hematological parameters. The investigators hypothesized that these parameters will differently adapt depending on the route of infusion
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 18, 2012
CompletedFirst Posted
Study publicly available on registry
February 28, 2012
CompletedFebruary 28, 2012
February 1, 2012
2 months
February 18, 2012
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Composition
. After having voided the bladder they were weighted to the nearest 0.1 kg and their heights were measured to the nearest 0.01 m with a estadiometer. Body mass was then calculated. Bioelectrical impedance analysis was performed with single-frequency (50 kHz) device (Bodystat 1500; Bodystat Ltd., Isle of Man, U.K.) using tetrapolar distal limb electrodes. TBW, fatty mass and lean body mass were calculated using regression equations programmed into the devices
2 hours
Secondary Outcomes (1)
Serum electrolytes
2 hours
Study Arms (2)
Oral Saline
EXPERIMENTALIngestion of 0.9% saline solution
Intravenous Saline
ACTIVE COMPARATORIntravenous infusion of 0.9% saline solution
Interventions
Ingestion of 2 L of 0.9% saline solution over 1h
Infusion of 2L of 0.9% saline solution over 1h
Eligibility Criteria
You may qualify if:
- Healthy young males (18-26 years) bearing no acute or chronic illness for the last 3 months previously to the experiment
You may not qualify if:
- Use of any drugs, tobacco, alcohol 2 months prior to the experiment. The investigators also planned to exclude those who for any reason do not comply with the protocols
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Julio Mullar
Cuiabá, Mato Grosso, 78000-000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose E Aguilar-Nascimento, MD, PhD
Federal University of Mato Grosso
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
February 18, 2012
First Posted
February 28, 2012
Study Start
August 1, 2011
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
February 28, 2012
Record last verified: 2012-02