B6 Treatment for Nausea and Vomiting in Pregnancy | NCT00763633

Studies
B6 Treatment for Nausea and Vomiting in Pregnancy

NCT00763633

Sponsor

Showa University

Status

Unknown status

Last Update Posted

Dec 31, 2008Estimated

Enrollment

150Estimated

Phase

Phase 4

Conditions

Nausea and Vomiting Complain in Early Pregnancy

Interventions

vitamin B6
vitamin B6

Countries

Indonesia

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Oct 2008Estimated

Completion Date

Oct 2008Estimated

First Submitted Date

Sep 29, 2008

First Submission Date that Met QC Criteria

Sep 29, 2008

First Posted Date

Oct 1, 2008Estimated

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

Dec 30, 2008

Last Update Posted Date

Dec 31, 2008Estimated

Name	Class
University of Bologna	OTHER

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 purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is effective in nausea and vomiting of pregnancy.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
highB6	Active Comparator	high vitamin B6	Drug: vitamin B6
lowB6	Active Comparator	low vitamin B6	Drug: vitamin B6

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamin B6	Drug	high dose of vitamin B6	highB6
vitamin B6

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nausea and vomiting score		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Vitamin B6 concentration in nausea and vomiting of pregnancy		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Nausea and vomiting of pregnancy

Exclusion Criteria:

Other medical condition causing nausea and vomiting of pregnancy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Noroyono Wibowo, MD, PhD	Contact	+6221 3915041		wibowonoroyono@yahoo.com
Yuditiya Purwosunu, MD	Contact	+6221 3915041		yudi@med.showa-u.ac.jp

Overall Officials

Name	Affiliation	Role
Noroyono Wibowo, MD, PhD	Dept. Obstetric Gynecology Univ. Indonesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Obstetric Gynecology Univ. Indonesia	Recruiting	Jakarta	Jakarta Special Capital Region	13210	Indonesia

Label	URL
Univ. Indonesia web-link	View source

Type	Date	Date Unknown
Release	Feb 16, 2010
Reset	Mar 5, 2010

Submission Tracking

Estimated Results First Submitted Date

Feb 16, 2010

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 16, 2010			Mar 5, 2010

Condition Browse Module

MeSH Terms

ID	Term
D009325	Nausea
D014839	Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D025101	Vitamin B 6

Ancestor Terms

ID	Term
D010847	Picolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided