Pregnancy Clinical Trial
Official title:
Kansas University DHA Outcome Study (KUDOS)
The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.
Status | Completed |
Enrollment | 350 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 36 Years |
Eligibility |
Inclusion Criteria: - Pregnant 8-20 wks at enrollment - single fetus - BMI <40 Exclusion Criteria: - diabetes (Type I, ii, GDM) - hypertension (primary, PIH, preeclampsia/eclampsia) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Truman Medical Center | Kansas City | Missouri |
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
Susan Carlson, PhD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Carlson SE, Colombo J, Gajewski BJ, Gustafson KM, Mundy D, Yeast J, Georgieff MK, Markley LA, Kerling EH, Shaddy DJ. DHA supplementation and pregnancy outcomes. Am J Clin Nutr. 2013 Apr;97(4):808-15. doi: 10.3945/ajcn.112.050021. Epub 2013 Feb 20. — View Citation
Ozias MK, Kerling EH, Christifano DN, Scholtz SA, Colombo J, Carlson SE. Typical prenatal vitamin D supplement intake does not prevent decrease of plasma 25-hydroxyvitamin D at birth. J Am Coll Nutr. 2014;33(5):394-9. doi: 10.1080/07315724.2013.879843. Ep — View Citation
Scholtz SA, Kerling EH, Shaddy DJ, Li S, Thodosoff JM, Colombo J, Carlson SE. Docosahexaenoic acid (DHA) supplementation in pregnancy differentially modulates arachidonic acid and DHA status across FADS genotypes in pregnancy. Prostaglandins Leukot Essent — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Total Fatty Acids by Weight | Measure of RBC-phospholipid-DHA at Birth | at time of birth | No |
Primary | Gestational Age | Gestational age of babies at time of birth in days | at time of birth | No |
Primary | Birth Weight | Weight of baby at birth | at time of birth | No |
Primary | Birth Length | Length of baby at birth | at time of birth | No |
Secondary | Ponderal Index | Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics. | at time of birth | No |
Secondary | Gender of Babies | at time of birth | No | |
Secondary | Cord RBC-phospholipid-DHA | Percentage of total fatty acids by weight in cord RBC | at time of birth | No |
Secondary | Head Circumference | Measure of circumference of baby's head in centimeters at time of birth. | at time of birth | No |
Secondary | Preterm Births | Percentage of births occurring at less than 37 weeks of gestation. | births before week 37 of gestation | No |
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