NCT00131690

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 1996

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1996

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
Last Updated

October 10, 2005

Status Verified

August 1, 2005

First QC Date

August 17, 2005

Last Update Submit

October 7, 2005

Conditions

Birth Weight

Keywords

CaffeineCoffeeRandomizedBirth weight

Outcome Measures

Primary Outcomes (2)

  • birth weight

  • gestational age

Interventions

Nescafé Gold Blend (exposed)DRUG
Nescafé Decaffeinated (controls)DRUG

Eligibility Criteria

Age0 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Epidemiology Science Centre

Vennelyst Boulevard 6, Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 17259189DERIVED

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jørn Olsen, Professor

    Danish Epidemiology Science Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 19, 2005

Study Start

April 1, 1996

Study Completion

August 1, 2002

Last Updated

October 10, 2005

Record last verified: 2005-08

Locations

DK(1)