NCT00345215

Brief Summary

The aim of the study is to test the hypothesis that the function and/or regulation of aquaporin 2 and/or endothelial sodium channels in the principal cells of healthy humans is abnormal at high and low sodium intake

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

7 months

First QC Date

June 24, 2006

Last Update Submit

June 27, 2011

Conditions

Healthy Humans

Keywords

Urinary Aquaporin 2High/low Sodium DietFractional Sodium Excretion

Outcome Measures

Primary Outcomes (3)

  • u-AQP-2

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • fractional sodium excretion

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • p-aldosterone

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Secondary Outcomes (6)

  • u-pAQP-2

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • u-ENaC(alfa-beta-gamma)

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • CH20

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • ucAMP

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • uPGE2

    Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  • +1 more secondary outcomes

Interventions

High Sodium DietBEHAVIORAL

250-350 mmol

Low Sodium DietBEHAVIORAL

25-35 mmol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caucasic men and women
  • Age 18-65 years
  • Body mass index less or equal to 30 Kg/m2

You may not qualify if:

  • Arterial hypertension
  • History or clinical signs of heart, brain, lung, kidney, malignant or endocrine organ disease.
  • Abnormal biochemical screening of the blood regarding: red and white cell count, B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumine, P- bilirubin, P-alanine aminotransferase, P- alkaline phosphatase, p-cholesterol and B-glucose.
  • Abnormal screening of the urine regarding: blood, albumine and glucose.
  • Alcohol or drug abuse
  • Drug use except oral contraceptives
  • Smoking
  • Abnormal electrocardiogram
  • Blood donation within one month of the first examination day
  • Pregnancy
  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, Holstebro Hospital

Holstebro, Holstebro, 7500, Denmark

Location

MeSH Terms

Interventions

Diet, Sodium-Restricted

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Erling B. Pedersen, Professor

    Department of Medical Research, Holstebro Hospital, Denmark

    STUDY CHAIR

  • Carolina C. Graffe, MD

    Department of Medical Research, Holstebro Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 24, 2006

First Posted

June 27, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2006

Study Completion

May 1, 2007

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations

DK(1)