Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health

Centre for Fetal Programming, Denmark

Status: Completed

Conditions: Atopy; Preterm Delivery; Metabolic Syndrome

Treatments: Dietary Supplement: Fish oil; Dietary Supplement: Olive oil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01353807

R21AT004603 (U.S. NIH Grant/Contract)

M-AA-20060182

Details and patient eligibility

About

The aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant women, while they were in gestational week 30, were randomized to fish oil supplements providing the mentioned amount of long chain n-3 fatty acids, olive oil supplements, or no supplements; they were asked to take the supplements until delivery. Health outcomes were assessed during pregnancy and delivery. Further, offspring health and development has been examined during the ensuring two decades by making linkages to the rich Danish health and administrative registries, by asking the offspring to complete web-based questionnaires, and by examining the offspring physically.

Enrollment: 533 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy pregnant women in gestation week 30

Exclusion criteria

• Bleeding episodes during pregnancy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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533 participants in 3 patient groups, including a placebo group

Fish oil supplementation

Active Comparator group

Description:

These women received 4 1-g capsules of fish oil per day providing 2,7 grams long chain n-3 fatty acids per day, from gestation week 30 until delivery

Treatment:

Dietary Supplement: Fish oil

Olive oil

Placebo Comparator group

Description:

These women received 4 1-g capsules with olive oil per day from gestational week 30 until delivery

Treatment:

Dietary Supplement: Olive oil

No oil supplement

No Intervention group

Description:

These women received no capsules with oil