Effect of Caffeine on Fetal Growth

Birth Weight Clinical Trial

Official title:

The Importance of Caffeine in Fetal Growth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131690
• Other study ID #: 1994/2974
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2005
• Last updated: October 7, 2005
• Start date: April 1996
• Est. completion date: August 2002

Study information

• Verified date: August 2005
• Source: The Danish Epdiemiology Science Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight

Intervention

Drug:
• Nescafé Gold Blend (exposed)

• Nescafé Decaffeinated (controls)

Locations

Country	Name	City	State
Denmark	Danish Epidemiology Science Centre	Vennelyst Boulevard 6	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
The Danish Epdiemiology Science Centre

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	birth weight
Primary	gestational age