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Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns

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ClinicalTrials.gov Identifier: NCT00320125
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : May 5, 2015
Sponsor:
Collaborator:
National Dairy Council, Rosemont, Illinois, USA
Information provided by:
University of Utah

Brief Summary:
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 or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: Orange juice plus calcium Dietary Supplement: Dairy products Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns
Study Start Date : March 2002
Primary Completion Date : June 2004
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Usual 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)



Primary Outcome Measures :
  1. Newborn bone mass
  2. Maternal dietary intakes

Secondary Outcome Measures :
  1. Newborn body weight
  2. Maternal blood pressure
  3. Newborn blood for calcium, phosphate, vitamin D


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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