Birth WeightPhase 4NCT00131690
Effect of Caffeine on Fetal Growth
A Phase 4 study testing Nescafé Gold Blend (exposed) in people with Birth Weight, run by The Danish Epdiemiology Science Centre at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether caffeine has any effect on birth weight. Read more about this study
- Who is it for?
- Ages 0 years and older, women only
- Conditions the study is for
- Birth Weight
- What is being tested?
- Nescafé Gold Blend (exposed)
- How many people
- 1,200 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 1996to Aug 2002
- 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 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant
- Consumption of at least 3 cups of coffee/day at recruitment
Who cannot join
- Gestational age more than 20 weeks at recruitment
- Chronic kidney disease
- Epilepsy
- Insulin dependent diabetes
- Metabolic disorder
- Previous low birth weight delivery
- Previous preterm delivery
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Epidemiology Science Centre
Vennelyst Boulevard 6, Aarhus, 8000
About this study
Official title: The Importance of Caffeine in Fetal Growth
The purpose of this study is to determine whether caffeine has any effect on birth weight.
- Conditions
- Birth Weight
- Being tested
- Nescafé Gold Blend (exposed), Nescafé Decaffeinated (controls)
- Keywords
- Caffeine, Coffee, Randomized, Birth weight
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nescafé Gold Blend (exposed)Drug
Nescafé Decaffeinated (controls)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
birth weight
gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startApr 1996
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth WeightStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- The Danish Epdiemiology Science Centre
- Sponsor type
- University, hospital or other
- Investigators
- Jørn Olsen, Professor, Study chair, Danish Epidemiology Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131690
- Sponsor's protocol ID
- 1994/2974
- Status last verified
- Aug 2005
- First submitted
- 17 Aug 2005
- Last updated
- 10 Oct 2005
- Results posted
- No
Publications
Bech BH, Obel C, Henriksen TB, Olsen J. Effect of reducing caffeine intake on birth weight and length of gestation: randomised controlled trial. BMJ. 2007 Feb 24;334(7590):409. doi: 10.1136/bmj.39062.520648.BE. Epub 2007 Jan 26.
PubMed 17259189
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Caffeine in Fetal Growth
- ClinicalTrials.gov ID
- NCT00131690
- Acronym / sponsor ID
- 1994/2974
- Conditions
- Birth Weight
- Keywords
- Caffeine, Coffee, Randomized, Birth weight
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- The Danish Epdiemiology Science CentreUniversity, hospital or other
- Study start
- Apr 1996
- Study completion
- Aug 2002
- First posted
- 19 Aug 2005 (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 whether caffeine has any effect on birth weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant
- Consumption of at least 3 cups of coffee/day at recruitment
Key exclusion criteria (7 listed)
- Gestational age more than 20 weeks at recruitment
- Chronic kidney disease
- Epilepsy
- Insulin dependent diabetes
- Metabolic disorder
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 |
|---|---|---|
| Nescafé Gold Blend (exposed) | Drug | – |
| Nescafé Decaffeinated (controls) | Drug | – |
Primary outcome
birth weight
gestational age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2005.
- Derived from this study: PubMed 17259189Bech BH, Obel C, Henriksen TB, Olsen J. Effect of reducing caffeine intake on birth weight and length of gestation: randomised controlled trial. BMJ. 2007 Feb 24;334(7590):409. doi: 10.1136/bmj.39062.520648.BE. Epub 2007 Jan 26.
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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.
Jørn Olsen, Professor study chair
Danish Epidemiology Science Centre
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 Nescafé Gold Blend (exposed) in people with Birth Weight, run by The Danish Epdiemiology Science Centre at 1 site in Denmark.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 10 Oct 2005. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
birth weight. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00131690, which also lists 1 linked publication.
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 10 Oct 2005.