NCT01982422

Developmental Origins of Attention Deficit Hyperactivity Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a study evaluating the relationship between prenatal nutrition and neural development in infants born to mothers with Attention Deficit Hyperactivity Disorder (ADHD). We are hypothesizing that women randomized to a whole food, nutrient-dense diet during their 3rd trimester of pregnancy will have infants with more advanced neural development as compared to infants born to mothers receiving standard-of-care treatment.

Detailed description

Pregnant women with ADHD will be recruited from the patient population at Oregon Health \& Science University (OHSU). They will be recruited during their 1st or 2nd trimester. After consent, baseline measures will be collected including height, weight, body composition measurements using calipers, 24-hour dietary recalls, and blood and urine samples. Women will also complete questionnaires regarding ADHD symptoms, stress, depression, and lifestyle. Women will be given a one-week food diary to fill out at home, which will be mailed in upon completion. Upon receipt of the food diary, women will be randomized into either a nutrition intervention group or a standard-of-care group. Women who are randomized to the intervention group will receive individual nutritional counseling every 2 weeks during their 3rd trimester of pregnancy. Before delivery, the baseline measures described above will again be collected. At delivery, placenta and cord blood samples will be taken. After birth, the infant will undergo an MRI between 2 and 5 weeks of age. The scan is completed while the baby sleeps, and special ear protection is worn to limit sleep disruption from the noise of the MRI. When the infant is 3 months old, mothers will complete questionnaires about infant feeding, sleep and behavior.

Conditions

• Inattention
• Impulsivity
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Whole Food, Nutrient-Dense Dietary Intervention	The dietary intervention will be a whole food, nutrient-dense diet which restricts processed foods high in food additives while optimizing micronutrient intake.
BEHAVIORAL	Standard of Care	Normal standard-of-care for pregnancy.

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-05-01
• Completion: 2014-08-01
• First posted: 2013-11-13
• Last updated: 2019-08-12

Locations

1 site across 1 country: United States