Developmental Origins of Attention Deficit Hyperactivity Disorder

NCT01982422 | Completed

• 1 other identifier: 6749
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Inattention; Impulsivity; Anxiety

Keywords

Attention Deficit and Hyperactivity Disorder; Nutrition; Diet; Developmental Origins of Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood nutrient concentrations

  Assessed at consent and end of 3rd trimester

Study Arms (2)

Dietary Intervention

EXPERIMENTAL

A whole food, nutrient-dense dietary intervention which restricts processed foods high in food additives and optimizes micronutrient intake.

Behavioral: Whole Food, Nutrient-Dense Dietary Intervention

Standard-of Care Group

PLACEBO COMPARATOR

This group will receive normal standard-of-care for pregnancy.

Behavioral: Standard of Care

Interventions

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.

Dietary Intervention

Standard of Care BEHAVIORAL

Normal standard-of-care for pregnancy.

Standard-of Care Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97223, United States

Location

MeSH Terms

Conditions

Impulsive Behavior; Anxiety Disorders; Attention Deficit Disorder with Hyperactivity; Developmental Origins of Health and Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Prenatal Exposure Delayed Effects; Prenatal Injuries; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Joel Nigg, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Psychology and Professor of Psychiatry

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 13, 2013
• Study Start: August 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 12, 2019

Record last verified: 2019-08

Locations

US (1)