Prenatal DHA and Neurofunctional Development (PANDA)

University of Kansas

Status: Completed

Conditions: Use and Dose of Prenatal DHA Supplementation

Treatments: Dietary Supplement: DHA 800mg; Dietary Supplement: DHA 200mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02709239

STUDY00003792

1R01HD086001 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to learn how much DHA to give to mothers in order to provide enough to the baby. Researchers will also learn if there are differences in development of the baby up to 12 months after birth.

Full description

Docosahexaenoic acid (DHA) is an essential nutrient. Our bodies make DHA from the foods we eat. If we eat foods with a lot of DHA, like fatty ocean fish, we have more DHA in our bodies. DHA is found in all cells of the body but is especially high in nerve cells of the brain and eye. Babies get DHA from the mother when they're in the womb. After birth, they can get DHA from breast milk or infant formulas.

This study will enroll pregnant women and follow them and their baby until the baby is 12 months old. Changes in the development of the baby will be tracked. Half of the participants in this study will receive 200mg of DHA to take daily. The other half of participants will receive 800mg of DHA to take daily. Participants, along with the researchers, will not know which dose of DHA they are receiving.

Enrollment: 300 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women in their 12th to 20th week of gestation
• Participants agree to consume the study capsules from enrollment to delivery
• Healthy weight, overweight and obese women (determined by body mass index; BMI) are eligible
• Must be available by telephone

Exclusion criteria

• Underweight women and women who exceed 250 lbs at enrollment
• Women with serious systemic infection, cancer, major organ disease or systemic lupus erythematosus
• Women with multiple infants or fetal diagnosis of congenital cardiac structural or conduction defects or brain malformations
• Diagnosis of Type I diabetes, and/or hypertension
• Reported drug and/or alcohol abuse
• Unwilling to take capsules, or be contacted by phone
• Do not understand English

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

DHA 200mg

Active Comparator group

Description:

Participants will receive 200mg DHA to take per day. Participants will be asked to take four capsules containing 50mg DHA each.

Treatment:

Dietary Supplement: DHA 200mg

DHA 800mg

Experimental group

Description:

Participants will receive 800mg DHA to take per day. Participants will be asked to take four capsules containing 200mg DHA each.

Treatment:

Dietary Supplement: DHA 800mg