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B6 Treatment for Nausea and Vomiting in Pregnancy

Primary Purpose

Nausea and Vomiting Complain in Early Pregnancy

Status
Unknown status
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
vitamin B6
vitamin B6
Sponsored by
Showa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea and Vomiting Complain in Early Pregnancy focused on measuring nausea, vomiting, pregnancy, B6

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Nausea and vomiting of pregnancy

Exclusion Criteria:

  • Other medical condition causing nausea and vomiting of pregnancy

Sites / Locations

  • Dept. Obstetric Gynecology Univ. IndonesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

highB6

lowB6

Arm Description

high vitamin B6

low vitamin B6

Outcomes

Primary Outcome Measures

Nausea and vomiting score

Secondary Outcome Measures

Vitamin B6 concentration in nausea and vomiting of pregnancy

Full Information

First Posted
September 29, 2008
Last Updated
December 30, 2008
Sponsor
Showa University
Collaborators
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT00763633
Brief Title
B6 Treatment for Nausea and Vomiting in Pregnancy
Official Title
Vitamin B6 Concentration and Treatment in Nausea and Vomiting of Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2008 (Anticipated)
Study Completion Date
October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Showa University
Collaborators
University of Bologna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting Complain in Early Pregnancy
Keywords
nausea, vomiting, pregnancy, B6

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
highB6
Arm Type
Active Comparator
Arm Description
high vitamin B6
Arm Title
lowB6
Arm Type
Active Comparator
Arm Description
low vitamin B6
Intervention Type
Drug
Intervention Name(s)
vitamin B6
Intervention Description
high dose of vitamin B6
Intervention Type
Drug
Intervention Name(s)
vitamin B6
Intervention Description
low vitamin B6
Primary Outcome Measure Information:
Title
Nausea and vomiting score
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Vitamin B6 concentration in nausea and vomiting of pregnancy
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Nausea and vomiting of pregnancy Exclusion Criteria: Other medical condition causing nausea and vomiting of pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noroyono Wibowo, MD, PhD
Phone
+6221 3915041
Email
wibowonoroyono@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuditiya Purwosunu, MD
Phone
+6221 3915041
Email
yudi@med.showa-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noroyono Wibowo, MD, PhD
Organizational Affiliation
Dept. Obstetric Gynecology Univ. Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Obstetric Gynecology Univ. Indonesia
City
Jakarta
ZIP/Postal Code
13210
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noroyono Wibowo, MD, PhD
Phone
+6221 3915041
Email
wibowonoroyono@yahoo.com
First Name & Middle Initial & Last Name & Degree
Noroyono Wibowo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Yuditiya Purwosunu, MD

12. IPD Sharing Statement

Links:
URL
http://www.ui.ac.id/en
Description
Univ. Indonesia web-link

Learn more about this trial

B6 Treatment for Nausea and Vomiting in Pregnancy

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