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NCT00320125 Clinical Trial

Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns

Pregnancy Clinical Trial

Official title:
Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00320125
Other study ID # 8818-01
Secondary ID
Status Completed
Phase Phase 3
First received April 28, 2006
Last updated May 1, 2015
Start date March 2002
Est. completion date June 2004

Study information
Verified date October 2008
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date June 2004
Est. primary completion date June 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 18 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Orange juice plus calcium
> 1,200mg Ca (four glasses of orange juice plus calcium)per day
• Dairy products
> 1,200mg Ca (by consuming milk, yogurt, and cheese)

Locations
Country Name City State
United States University Hospital Salt Lake City Utah

Sponsors (2)
Lead Sponsor Collaborator
University of Utah National Dairy Council, Rosemont, Illinois, USA

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Newborn bone mass
Primary Maternal dietary intakes
Secondary Newborn body weight
Secondary Maternal blood pressure
Secondary Newborn blood for calcium, phosphate, vitamin D
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