Nausea and Vomiting Complain in Early PregnancyPhase 4NCT00763633
B6 Treatment for Nausea and Vomiting in Pregnancy
A Phase 4 study testing vitamin B6 in people with Nausea and Vomiting Complain in Early Pregnancy, run by Showa University at 1 site in Indonesia.
Trial summary
The purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is effective in nausea and vomiting of pregnancy. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nausea and Vomiting Complain in Early Pregnancy
- What is being tested?
- vitamin B6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndonesia
- Study dates
- Jan 2008to Oct 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Nausea and vomiting of pregnancy
Who cannot join
- Other medical condition causing nausea and vomiting of pregnancy
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dept. Obstetric Gynecology Univ. Indonesia
Jakarta, Jakarta Special Capital Region, 13210
Noroyono Wibowo, MD, PhD, +6221 3915041, wibowonoroyono@yahoo.com
Noroyono Wibowo, MD, PhD
About this study
Official title: 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.
- Being tested
- vitamin B6
- Keywords
- nausea, vomiting, pregnancy, B6
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin B6Drug
high dose of vitamin B6
vitamin B6Drug
low vitamin B6
| Study group | Role | What they receive |
|---|---|---|
| highB6 | Active comparator | high vitamin B6 Receives: Drug: vitamin B6 |
| lowB6 | Active comparator | low vitamin B6 Receives: Drug: vitamin B6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea and vomiting score
Measured: 2 weeks
Secondary outcomes (1)
Vitamin B6 concentration in nausea and vomiting of pregnancy
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting Complain in Early PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Showa University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Investigators
- Noroyono Wibowo, MD, PhD, Principal investigator, Dept. Obstetric Gynecology Univ. Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763633
- Sponsor's protocol ID
- B601
- Status last verified
- Sep 2008
- First submitted
- 29 Sep 2008
- Last updated
- 31 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin B6 Concentration and Treatment in Nausea and Vomiting of Pregnancy
- ClinicalTrials.gov ID
- NCT00763633
- Acronym / sponsor ID
- B601
- Keywords
- nausea, vomiting, pregnancy, B6
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Showa UniversityUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is effective in nausea and vomiting of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| highB6 | Active comparator | Drug: vitamin B6high vitamin B6 |
| lowB6 | Active comparator | Drug: vitamin B6low vitamin B6 |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Nausea and vomiting of pregnancy
Key exclusion criteria (1 listed)
- Other medical condition causing nausea and vomiting of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin B6high dose of vitamin B6 | Drug | highB6 |
| vitamin B6low vitamin B6 | Drug | lowB6 |
Primary outcome
Nausea and vomiting score
Time frame: 2 weeks
1 secondary outcome
Vitamin B6 concentration in nausea and vomiting of pregnancy
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
- Univ. Indonesia web-linkLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noroyono Wibowo, MD, PhD principal investigator
Dept. Obstetric Gynecology Univ. Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vitamin B6 in people with Nausea and Vomiting Complain in Early Pregnancy, run by Showa University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noroyono Wibowo, MD, PhD (+6221 3915041, wibowonoroyono@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea and vomiting score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2008.