NCT01123759

Brief Summary

Fish can provide pregnant women with omega-3 fatty acids for fetal brain development but some fish contains high levels of mercury which is detrimental to fetal brain development. The hypothesis is that women who have previously consumed high mercury fish can reduce the mercury level in their bodies and improve their omega-3 levels in three months by eating fish that is high in omega-3 fatty acids and low in mercury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
Last Updated

May 14, 2010

Status Verified

May 1, 2010

Enrollment Period

1.9 years

First QC Date

May 12, 2010

Last Update Submit

May 13, 2010

Conditions

Infant Brain Health

Keywords

Fishmercuryomega-3 fatty acidsinfantbrain developmentpregnancynursing motherdietary recommendationsHair mercuryBlood mercuryRecommendations for pregnant or nursing womenInfant brain health

Outcome Measures

Primary Outcomes (1)

  • Hair Mercury

    The hair mercury after feeding low mercury fish for 3 months

    3 months

Secondary Outcomes (2)

  • Blood mercury concentration

    3 months

  • Blood omega-3 fatty acid concentrations

    3 months

Study Arms (2)

Tilapia

ACTIVE COMPARATOR

Subjects are fed 6 oz tilapia once a week for 3 months

Other: Feeding low mercury fish

Salmon

ACTIVE COMPARATOR

Subjects fed 6 oz salmon once a week for 3 months

Other: Feeding low mercury fish

Interventions

Feeding low mercury fishOTHER

Subjects fed 6 oz of either tilapia (low omega-3 fish) or salmon (high omega-3 fish) for 3 months. Both fish are low in mercury

SalmonTilapia

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Hair mercury levels equal to or greater than 0.8 ppm

You may not qualify if:

  • Pregnant or planning to become pregnant in the next 3 months
  • Nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida A&M University

Tallahassee, Florida, 32307-4100, United States

Location

Purdue University, Department of Foods and Nutrition

West Lafayette, Indiana, 47907-2059, United States

Location

Study Officials

  • Charles Santerre, Ph.D

    Purdue University, Department of Foods and Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2010

First Posted

May 14, 2010

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 14, 2010

Record last verified: 2010-05

Locations

US(2)