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Completed

NCT Number: NCT01982422

Developmental Origins of Attention Deficit Hyperactivity Disorder

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.

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Key information

Conditions

Inattention Anxiety Anxiety Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Developmental Origins of Health and Disease Female Urogenital Diseases and Pregnancy Complications Impulsive Behavior Impulsivity Mental Disorders Neurodevelopmental Disorders Pregnancy Complications Prenatal Exposure Delayed Effects Prenatal Injuries Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97223, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Food, Nutrient-Dense Dietary Intervention

Behavioral

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

Behavioral

Normal standard-of-care for pregnancy.

Primary outcomes

  1. Functional neuroconnectivity of neonate assessed by MRI

    Time frame: 2-5 weeks after birth

    MRI will be used to examine brain morphology and functional connectivity in the neonates.

Secondary outcomes

  1. Blood nutrient concentrations

    Time frame: Assessed at consent and end of 3rd trimester

    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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 13, 2013
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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