B6 Treatment for Nausea and Vomiting in Pregnancy

December 30, 2008 updated by: Showa University

Vitamin B6 Concentration and Treatment in Nausea and Vomiting of Pregnancy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 13210
        • Recruiting
        • Dept. Obstetric Gynecology Univ. Indonesia
        • Contact:
        • Principal Investigator:
          • Noroyono Wibowo, MD, PhD
        • Sub-Investigator:
          • Yuditiya Purwosunu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nausea and vomiting of pregnancy

Exclusion Criteria:

  • Other medical condition causing nausea and vomiting of pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: highB6
high vitamin B6
Drug: vitamin B6
high dose of vitamin B6
Drug: vitamin B6
low vitamin B6
Active Comparator: lowB6
low vitamin B6
Drug: vitamin B6
high dose of vitamin B6
Drug: vitamin B6
low vitamin B6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nausea and vomiting score
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Showa University

Collaborators

University of Bologna

Investigators

  • Principal Investigator: Noroyono Wibowo, MD, PhD, Dept. Obstetric Gynecology Univ. Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

October 1, 2008

Study Completion (Anticipated)

October 1, 2008

Study Registration Dates

First Submitted

September 29, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

December 31, 2008

Last Update Submitted That Met QC Criteria

December 30, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nausea and Vomiting Complain in Early Pregnancy

Clinical Trials on vitamin B6

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe