Effect of Caffeine on Fetal Growth - Full Text View

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

ChemIDplus related topics:

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:

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. Epub 2007 Jan 26.

Study ID Numbers:	1994/2974
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 October 03, 2008