NCT03847571

Brief Summary

In this prospective controlled cross over clinical trial, the investigators aim to evaluate the efficacy and safety of acetazolamide for the management of metabolic alkalosis in children with Bartter syndrome. Urine and blood electrolytes will be measured before and after acetazolamide treatment. The primary end point is a change in polyuria, hypokalemia, and metabolic alkalosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

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

January 10, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

February 16, 2019

Last Update Submit

February 19, 2019

Conditions

Bartter Syndrome

Keywords

AcetazolamideHypokalemic metabolic alkalosisBartter syndrome

Outcome Measures

Primary Outcomes (2)

  • Metabolic alkalosis

    Change in serum bicarbonate level

    4 weeks

  • Urine output

    Change in 24-hr urine volume

    4 weeks

Study Arms (1)

Acetazolamide

Oral administration of acetazolamide 5 mg/kg/day for 4 weeks

Drug: Acetazolamide

Interventions

AcetazolamideDRUG

Correction of metabolic alkalosis by inhibition of the filtered bicarbonate load reabsorption in the proximal tubules using acetazolamide (AZ)

Acetazolamide

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children between 1 and 10 years of age with failure to thrive, polyuria and unexplained hypokalemic metabolic alkalosis will be recruited for this trial.

You may qualify if:

  • Hypokalemia
  • metabolic alkalosis
  • normal blood pressure
  • random urine chloride \>20 milliequivalent per liter (mEq/L)
  • Elevated serum aldosterone and renin levels

You may not qualify if:

  • Hypertension
  • History of emesis
  • Prior use of laxatives
  • Cystic fibrosis ofpancrease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fateme Ghane Sharbaf

Mashhad, Iran

RECRUITING

Semnan University of Medical Sciences

Semnan, 011000, Iran

RECRUITING

Banafshe Dormansh

Tehran, Iran

NOT YET RECRUITING

Simin Sadeghi

Zahedan, Iran

RECRUITING

MeSH Terms

Conditions

Bartter Syndrome

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Renal Tubular Transport, Inborn ErrorsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHyperaldosteronismAdrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Farahnak Assadi, MD

    Rush University Medical Center

    STUDY DIRECTOR

Central Study Contacts

Farahnak Assadi, MD

CONTACT

3125600477fassadi@rush.edu

Mojgan Mazaheri, MD

CONTACT

00-98 9123069789mojganmazaheri@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2019

First Posted

February 20, 2019

Study Start

January 10, 2019

Primary Completion

October 30, 2019

Study Completion

December 30, 2019

Last Updated

February 20, 2019

Record last verified: 2019-02

Locations

IR(4)