Clinical trial NCT01982422: Developmental Origins of Attention Deficit Hyperactivity Disorder
Official title: Developmental Origins of Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inattention
Impulsivity
Anxiety
Keywords: Attention Deficit and Hyperactivity Disorder
Nutrition
Diet
Developmental Origins of Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Women in general good health
* 18 years of age or older
* Confirmed pregnancy and currently between 8 and 24 weeks pregnant
* With symptoms of inattention or impulsivity

Exclusion Criteria:

* Obstetrician confirmed high-risk pregnancy
* Current drug/alcohol addiction
* Current smoker
* Unwilling/unable to discontinue psychiatric medication during pregnancy
* Comorbid schizophrenia, bipolar, or major depressive disorder

Primary outcomes:
measure: Functional neuroconnectivity of neonate assessed by MRI
timeFrame: 2-5 weeks after birth
Secondary outcomes:
measure: Blood nutrient concentrations
timeFrame: Assessed at consent and end of 3rd trimester
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Joel Nigg, PhD
role: PRINCIPAL_INVESTIGATOR
References: