Status:
UNKNOWN
DHA Supplements to Improve Insulin Sensitivity in Obese Pregnant Women (The Omega-3 Pregnancy Study)
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsors:
Office of Research on Women's Health (ORWH)
Mead Johnson Nutrition
Conditions:
Overweight and Obesity
Insulin Resistance
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
Brief Summary
Women with excess adiposity while pregnant are more likely to develop gestational diabetes and high blood pressure during pregnancy than women of healthy weights. This may occur because overweight and...
Detailed Description
The effects of overweight and obesity during pregnancy on maternal and child health can be serious and long lasting. Overweight and obese women are more likely to develop gestational diabetes or pre-e...
Eligibility Criteria
Inclusion
- Pre-pregnant body mass index greater than 25
- Singleton pregnancy
- Speaks English
Exclusion
- High intake of DHA foods (i.e., more than 1 fish meal per week, use of DHA-fortified foods, or use of any supplements that contain DHA)
- Concurrent inflammatory, vascular, or metabolic disease, including diabetes, polycystic ovary disease, collagen vascular disease, inflammatory bowel disease, or infection
- Current or previous use of tobacco, street drugs, or medications known to affect inflammatory markers, including corticosteroids
- Excessive weight gain or loss before pregnancy (more than 20 pounds), including weight loss due to bariatric surgery
- Plans to leave the area during the study period
- Inability to travel to General Clinical Research Center
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00865683
Start Date
April 1 2009
End Date
July 1 2011
Last Update
July 15 2009
Active Locations (1)
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1
General Clinical Research Center
Cincinnati, Ohio, United States, 45229-3039