NCT00865683

Brief Summary

Women with excess adiposity while pregnant are more likely to develop gestational diabetes and high blood pressure during pregnancy than women of healthy weights. This may occur because overweight and obese pregnant women are less sensitive to insulin and have more inflammation than pregnant women of healthy weights. This study will examine the effect of a nutritional supplement, docosahexaenoic acid (DHA), on improving insulin sensitivity and lessening inflammation in overweight and obese pregnant women.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 15, 2009

Status Verified

July 1, 2009

Enrollment Period

2.2 years

First QC Date

March 17, 2009

Last Update Submit

July 14, 2009

Conditions

Overweight and ObesityInsulin ResistanceDiabetes, GestationalHypertension in PregnancyPre-Eclampsia

Keywords

Gestational DiabetesPregnancyDocosahexaenoic AcidDHAMaternal-Fetal Exchange

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Measured at approximately Month 3

Secondary Outcomes (1)

  • Interleukin-6 (IL-6)

    Measured at approximately Month 3

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will receive DHA supplements.

Dietary Supplement: DHA Supplements

2

PLACEBO COMPARATOR

Participants will receive placebo capsules of corn oil.

Dietary Supplement: Placebo Supplements

Interventions

DHA SupplementsDIETARY_SUPPLEMENT

Participants will receive 800 mg of DHA each day for approximately 3 months (until they give birth).

1
Placebo SupplementsDIETARY_SUPPLEMENT

Participants will receive placebo supplements each day for approximately 3 months (until they give birth).

2

Eligibility Criteria

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

You may qualify if:

  • Pre-pregnant body mass index greater than 25
  • Singleton pregnancy
  • Speaks English

You may not qualify if:

  • High intake of DHA foods (i.e., more than 1 fish meal per week, use of DHA-fortified foods, or use of any supplements that contain DHA)
  • Concurrent inflammatory, vascular, or metabolic disease, including diabetes, polycystic ovary disease, collagen vascular disease, inflammatory bowel disease, or infection
  • Current or previous use of tobacco, street drugs, or medications known to affect inflammatory markers, including corticosteroids
  • Excessive weight gain or loss before pregnancy (more than 20 pounds), including weight loss due to bariatric surgery
  • Plans to leave the area during the study period
  • Inability to travel to General Clinical Research Center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Clinical Research Center

Cincinnati, Ohio, 45229-3039, United States

RECRUITING

Related Publications (1)

  • Lager S, Ramirez VI, Acosta O, Meireles C, Miller E, Gaccioli F, Rosario FJ, Gelfond JAL, Hakala K, Weintraub ST, Krummel DA, Powell TL. Docosahexaenoic Acid Supplementation in Pregnancy Modulates Placental Cellular Signaling and Nutrient Transport Capacity in Obese Women. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4557-4567. doi: 10.1210/jc.2017-01384.

    PMID: 29053802DERIVED

Related Links

MeSH Terms

Conditions

OverweightObesityInsulin ResistanceDiabetes, GestationalHypertension, Pregnancy-InducedPre-Eclampsia

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusEndocrine System DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Debra A. Krummel, PhD, RD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Debra A. Krummel, PhD, RD

CONTACT

513-558-8537debra.krummel@uc.edu

Margaret Andrews, MD, MS, RD

CONTACT

513-558-7042margaret.andrews@uc.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 19, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 15, 2009

Record last verified: 2009-07

Locations

US(1)