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Trial of Fish Intake Advice in Pregnancy

A Pilot Randomized Controlled Trial to Promote Healthful Fish Consumption in Pregnancy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01126762
Enrollment
61
Registered
2010-05-20
Start date
2010-05-31
Completion date
2011-06-30
Last updated
2012-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition

Keywords

Docosahexaenoic acid, fish, pregnancy, methylmercury, n-3 polyunsaturated fatty acid

Brief summary

The overall goal of this project is to establish a pilot study to develop and refine an intervention to promote consumption of fish low in mercury and high in n-3 PUFA among pregnant women. The investigators will demonstrate our ability to recruit pregnant women, influence their fish consumption, and measure changes in nutrient and toxicant biomarkers.

Interventions

BEHAVIORALDietary advice

Dietary advice regarding consumption of low mercury, high DHA fish

BEHAVIORALControl

Advice regarding healthful diet during pregnancy, not focused on fish intake

Sponsors

Harvard School of Public Health (HSPH)
CollaboratorOTHER
Harvard University
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
National Institute of Environmental Health Sciences (NIEHS)
CollaboratorNIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Harvard Pilgrim Health Care
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* age 18 years or older * Currently pregnant 12-22 weeks * Singleton pregnancy * Consuming fish \<=2 times per month

Exclusion criteria

* Inability to answer questionnaires in English * Plans to leave study area prior to delivery * Would never eat fish (e.g. vegan, allergy to fish)

Design outcomes

Primary

MeasureTime frameDescription
Plasma elongated n-3 PUFA levels12 weeksChange in plasma levels of elongated n-3 PUFA from recruitment to follow up at 12 weeks

Secondary

MeasureTime frameDescription
Whole blood mercury12 weeksChange in whole blood total mercury level from recruitment to 12 weeks
Fish consumption12 weeksChange in fish consumption from recruitment to 12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026