Developmental Origins of Attention Deficit Hyperactivity Disorder

Anxiety Clinical Trial

Official title:

Developmental Origins of Attention Deficit Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982422
• Other study ID #: 6749
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis
• Impulsive Behavior
• Impulsivity
• Inattention

Intervention

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.
• Standard of Care
Normal standard-of-care for pregnancy.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional neuroconnectivity of neonate assessed by MRI	MRI will be used to examine brain morphology and functional connectivity in the neonates.	2-5 weeks after birth
Secondary	Blood nutrient concentrations	Maternal blood nutrient concentrations will be examined to assess whether or not the intervention group had higher nutrient levels in the 3rd trimester than the standard-of-care group.	Assessed at consent and end of 3rd trimester