NCT00763633

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 31, 2008

Status Verified

September 1, 2008

Enrollment Period

9 months

First QC Date

September 29, 2008

Last Update Submit

December 30, 2008

Conditions

Nausea and Vomiting Complain in Early Pregnancy

Keywords

nauseavomitingpregnancyB6

Outcome Measures

Primary Outcomes (1)

  • Nausea and vomiting score

    2 weeks

Secondary Outcomes (1)

  • Vitamin B6 concentration in nausea and vomiting of pregnancy

    2 weeks

Study Arms (2)

highB6

ACTIVE COMPARATOR

high vitamin B6

Drug: vitamin B6

lowB6

ACTIVE COMPARATOR

low vitamin B6

Drug: vitamin B6

Interventions

vitamin B6DRUG

high dose of vitamin B6

highB6

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Nausea and vomiting of pregnancy

You may not qualify if:

  • Other medical condition causing nausea and vomiting of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Obstetric Gynecology Univ. Indonesia

Jakarta, Jakarta Special Capital Region, 13210, Indonesia

RECRUITING

Related Links

MeSH Terms

Conditions

NauseaVomiting

Interventions

Vitamin B 6

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Noroyono Wibowo, MD, PhD

    Dept. Obstetric Gynecology Univ. Indonesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noroyono Wibowo, MD, PhD

CONTACT

+6221 3915041wibowonoroyono@yahoo.com

Yuditiya Purwosunu, MD

CONTACT

+6221 3915041yudi@med.showa-u.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2008

First Posted

October 1, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 31, 2008

Record last verified: 2008-09

Locations

ID(1)