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CompletedNCT00320125Updated May 5, 2015

Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns

A Phase 3 interventional study of Orange juice plus calcium and Dairy products in Pregnancy, sponsored by University of Utah. Completed at 1 site in United States. Open to female participants aged 15 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-05.

Sponsored by University of Utah · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
15 Years to 18 Years
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Pregnancy

Keywords

  • Dairy
  • Calcium
  • Pregnancy
  • Fetus
  • Bone mineralization
03

In context

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 18 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Pregnant mothers aged 15 to 18 years, term gestation

Exclusion criteria

Exclusion Criteria:

  • Chronic disease such as hypertension, diabetes, medications that will affect calcium metabolism
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • No intervention
    1

    Usual diet

  • Active comparator
    2

    Orange juice fortified with calcium

    Dietary Supplement: Orange juice plus calcium

  • Active comparator
    3

    Dairy products

    Dietary Supplement: Dairy products

Interventions

  • Dietary supplementOrange juice plus calcium

    \> 1,200mg Ca (four glasses of orange juice plus calcium)per day

  • Dietary supplementDairy products

    \> 1,200mg Ca (by consuming milk, yogurt, and cheese)

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What researchers measure

Primary outcomes

  1. Newborn bone mass

  2. Maternal dietary intakes

Secondary outcomes

  1. Newborn body weight

  2. Maternal blood pressure

  3. Newborn blood for calcium, phosphate, vitamin D

07

Study locations

1 site
  • University Hospital
    Salt Lake City, Utah 84132, United States
08

References and documents

Publications

  • Thomas M, Weisman SM. Calcium supplementation during pregnancy and lactation: effects on the mother and the fetus. Am J Obstet Gynecol. 2006 Apr;194(4):937-45. doi: 10.1016/j.ajog.2005.05.032. PubMed 16580279 ↗
  • Koo WW, Walters JC, Esterlitz J, Levine RJ, Bush AJ, Sibai B. Maternal calcium supplementation and fetal bone mineralization. Obstet Gynecol. 1999 Oct;94(4):577-82. doi: 10.1016/s0029-7844(99)00371-3. PubMed 10511362 ↗
  • Merrilees MJ, Smart EJ, Gilchrist NL, Frampton C, Turner JG, Hooke E, March RL, Maguire P. Effects of diary food supplements on bone mineral density in teenage girls. Eur J Nutr. 2000 Dec;39(6):256-62. doi: 10.1007/s003940070004. PubMed 11395985 ↗
  • Chan GM, McElligott K, McNaught T, Gill G. Effects of dietary calcium intervention on adolescent mothers and newborns: A randomized controlled trial. Obstet Gynecol. 2006 Sep;108(3 Pt 1):565-71. doi: 10.1097/01.AOG.0000231721.42823.9e. PubMed 16946216 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00320125
Lead sponsor
University of Utah
Collaborators
National Dairy Council, Rosemont, Illinois, USA
First posted
May 3, 2006
Start date
Mar 2002
Primary completion
Jun 2004
Completion
Jun 2004
Last update
May 5, 2015

Study contacts

Gary M Chan, MD
principal investigator · University of Utah
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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