Effect of Caffeine on Fetal Growth

Sponsor
The Danish Epdiemiology Science Centre (Other)
Overall Status
Completed
CT.gov ID
NCT00131690
Collaborator
(none)
1,200
1
76
15.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Nescafé Gold Blend (exposed)
  • Drug: Nescafé Decaffeinated (controls)
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
The Importance of Caffeine in Fetal Growth
Study Start Date :
Apr 1, 1996
Study Completion Date :
Aug 1, 2002

Outcome Measures

Primary Outcome Measures

  1. birth weight []

  2. gestational age []

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00131690
Other Study ID Numbers:
  • 1994/2974
First Posted:
Aug 19, 2005
Last Update Posted:
Oct 10, 2005
Last Verified:
Aug 1, 2005
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2005