Lime Powder Regimen in Healthy Volunteers | NCT01273025

Studies
Lime Powder Regimen in Healthy Volunteers

NCT01273025

Sponsor

Chulalongkorn University

Status

Unknown status

Last Update Posted

Jan 10, 2011Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Kidney Stone
Oxidative Stress

Interventions

Lime powder regime

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Mar 2011Estimated

Completion Date

Mar 2011Estimated

First Submitted Date

Jan 5, 2011

First Submission Date that Met QC Criteria

Jan 7, 2011

First Posted Date

Jan 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2011

Last Update Posted Date

Jan 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to investigate the pharmacokinetic parameters and its antioxidative effects in Thai healthy men.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lime powder regime	Dietary Supplement	1 sachet of lime powder regimen with 200 ml of water

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The pharmacokinetic parameters of plasma and urine citrate	The pharmacokinetic parameters of plasma and urine citrate incluiding Cmax, Tmax, Half life, AUC, and elimination rate constant	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Thai healthy male or female aged 18-45 years old
BMI 18-25 kg/m2
Normal medical history, physical examination and vital signs
Normal screening laboratories
no history of drug allergies
Willingness to take part in the study and provide informed consent

Exclusion Criteria:

History of GI, liver, kidney, allergic disease or any other disease that may interfere with the bioavailability of lime powder regimen
History of alcohol or drug abuse
Heavy smoking
Receive any medication within 14 days prior to the study day

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Poonsin Poungpairoj, BSc	Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chula clinical research center		Bangkok		10330	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided