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Effect of Caffeine on Fetal Growth
This study has been completed.
Sponsored by: The Danish Epdiemiology Science Centre
Information provided by: The Danish Epdiemiology Science Centre
ClinicalTrials.gov Identifier: NCT00131690
  Purpose

The purpose of this study is to determine whether caffeine has any effect on birth weight.


Condition Intervention Phase
Birth Weight
Drug: Nescafé Gold Blend (exposed)
Drug: Nescafé Decaffeinated (controls)
Phase IV

MedlinePlus related topics: Caffeine
Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: The Importance of Caffeine in Fetal Growth

Further study details as provided by The Danish Epdiemiology Science Centre:

Primary Outcome Measures:
  • birth weight
  • gestational age

Estimated Enrollment: 1200
Study Start Date: April 1996
Estimated Study Completion Date: August 2002
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant
  • Consumption of at least 3 cups of coffee/day at recruitment

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131690

Locations
Denmark, Aarhus
Danish Epidemiology Science Centre
Vennelyst Boulevard 6, Aarhus, Denmark, 8000
Sponsors and Collaborators
The Danish Epdiemiology Science Centre
Investigators
Study Chair: Jørn Olsen, Professor Danish Epidemiology Science Centre
  More Information

Publications indexed to this study:
Study ID Numbers: 1994/2974
Study First Received: August 17, 2005
Last Updated: October 7, 2005
ClinicalTrials.gov Identifier: NCT00131690  
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by The Danish Epdiemiology Science Centre:
Caffeine
Coffee
Randomized
Birth weight

Study placed in the following topic categories:
Caffeine citrate
Body Weight
Birth Weight
Signs and Symptoms
Caffeine

Additional relevant MeSH terms:
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants
Enzyme Inhibitors
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009