B6 Treatment for Nausea and Vomiting in Pregnancy

NCT ID: NCT00763633

Last Updated: 2008-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-10-31

Brief Summary

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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

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Conditions

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Nausea and Vomiting Complain in Early Pregnancy

Keywords

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nausea vomiting pregnancy B6

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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highB6

high vitamin B6

Group Type ACTIVE_COMPARATOR

vitamin B6

Intervention Type DRUG

high dose of vitamin B6

lowB6

low vitamin B6

Group Type ACTIVE_COMPARATOR

vitamin B6

Intervention Type DRUG

low vitamin B6

Interventions

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vitamin B6

high dose of vitamin B6

Intervention Type DRUG

vitamin B6

low vitamin B6

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Nausea and vomiting of pregnancy

Exclusion Criteria

* Other medical condition causing nausea and vomiting of pregnancy
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bologna

OTHER

Sponsor Role collaborator

Showa University

OTHER

Sponsor Role lead

Responsible Party

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Univ. Indonesia

Principal Investigators

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Noroyono Wibowo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. Obstetric Gynecology Univ. Indonesia

Locations

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Dept. Obstetric Gynecology Univ. Indonesia

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Noroyono Wibowo, MD, PhD

Role: CONTACT

Phone: +6221 3915041

Email: [email protected]

Yuditiya Purwosunu, MD

Role: CONTACT

Phone: +6221 3915041

Email: [email protected]

Facility Contacts

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Noroyono Wibowo, MD, PhD

Role: primary

Related Links

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http://www.ui.ac.id/en

Univ. Indonesia web-link

Other Identifiers

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B601

Identifier Type: -

Identifier Source: org_study_id