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Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns

This study has been completed.
Sponsor:
Collaborator:
National Dairy Council, Rosemont, Illinois, USA
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00320125
First received: April 28, 2006
Last updated: October 9, 2008
Last verified: October 2008
History of Changes
  Purpose

The purpose of the study is to evaluate the effects of different dietary calcium have on the pregnant teen mother and her newborn. We hypothesize that the higher calcium intake during pregnancy will result in higher bone mass in the newborn.


Condition Intervention Phase
Pregnancy
 Other: Usual diet
Dietary Supplement: Orange juice plus calcium
Dietary Supplement: Dairy products
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Newborn bone mass
  • Maternal dietary intakes

Secondary Outcome Measures:
  • Newborn body weight
  • Maternal blood pressure
  • Newborn blood for calcium, phosphate, vitamin D

Enrollment: 72
Study Start Date: March 2002
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Usual diet
 Other: Usual diet
Usual prestudy diet
Active Comparator: 2
Orange juice fortified with calcium
 Dietary Supplement: Orange juice plus calcium
> 1,200mg Ca (four glasses of orange juice plus calcium)per day
Active Comparator: 3
Dairy products
 Dietary Supplement: Dairy products
> 1,200mg Ca (by consuming milk, yogurt, and cheese)

Detailed Description:

Osteoporosis in the adult remains a significant public health problem. One of the major causes of osteoporosis is the inadequate calcium intake during the pediatric age range of birth to 20 years of age. We believe that this low calcium may start at birth since the fetus is actively accumulating calcium during the last trimester of pregnancy. Adolescents generally have poor calcium intake. Our study is to compare the newborn bone mass from adolescent mothers who are taking the recommended calcium intake from dairy foods or non-dairy foods such as orange juice during pregnancy.

  Eligibility

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant mothers aged 15 to 18 years, term gestation

Exclusion Criteria:

  • Chronic disease such as hypertension, diabetes, medications that will affect calcium metabolism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320125

Locations
United States, Utah
University Hospital
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
National Dairy Council, Rosemont, Illinois, USA
Investigators
Principal Investigator: Gary M Chan, MD University of Utah
  More Information

Additional Information:
national osteoporosis organization  This link exits the ClinicalTrials.gov site
NIH osteoporosis resource center  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Gary M Chan, MD Primary Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT00320125     History of Changes
Other Study ID Numbers: 8818-01
Study First Received: April 28, 2006
Last Updated: October 9, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Dairy
Calcium
Pregnancy
Fetus
Bone mineralization

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013