Omega-3 Supplementation Decreases Inflammation and Fetal Obesity in Pregnancy

NCT00957476 | Completed DMC

• 2 other identifiers: IRB06-00255R01HD057236
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, double-blind placebo controlled trial of fish oil to decrease inflammation in pregnancy.

Conditions

Inflammation; Obesity; Pregnancy; Fetal Growth

Keywords

Pregnancy; Metabolic Diseases; Obesity; Fetal adiposity; Omega-3; Inflammation; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Decreased inflammation during human pregnancy

  cytokine concentration in plasma, placenta and white adipose tissue

  enrollment (8-16 weeks) to delivery

Secondary Outcomes (1)

• Reduction of insulin resistance

  enrollment (8-16 weeks) to delivery

Study Arms (2)

Omega-3 Fish Oil

ACTIVE COMPARATOR

800mg DHA \& 1200mg EPA

Dietary Supplement: Omega-3 Fish Oil

Placebo

PLACEBO COMPARATOR

Wheat germ oil

Dietary Supplement: Omega-3 Fish Oil

Interventions

Omega-3 Fish Oil DIETARY_SUPPLEMENT

800mg DHA and 1200mg EPA or the equivalent of a placebo PO (by mouth) once a day from enrollment (prior to 16 weeks gestation) until delivery.

Omega-3 Fish Oil; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI (wt/ht2) \> or = 25 at first antenatal visit
• Gestational age at randomization between 8-16 weeks
• No medical problems such as hyperlipidemia, hypertension, or pregestational diabetes
• Between the ages of 18 and 40 years old
• Non-smokers
• No obstetrical problems such as a history of preeclampsia or gestational diabetes
• Confirmed singleton pregnancy

You may not qualify if:

• Major fetal anomaly
• Regular intake of fish oil supplements (defined as greater than 500 mg per week within the last four weeks). This is due to the placebo group receiving fish oil outside of the study.
• Daily use of nonsteroidal anti-inflammatory agents
• Allergy to fish or fish products, gluten intolerant (because the placebo contains wheat germ oil, which is not gluten free).
• Women who are vegetarians and do not eat any fish.
• Infants born preterm (less than 36 weeks gestation) or less than 2kg.
• Heparin use or known thrombophilia (thrombophilias include homozygous for Factor V Leiden).
• Moderate or high titer IgG anticardiolipin antibodies or prolonged activated PTT or other indication of presence of lupus anticoagulant, homozygous for prothrombin gene (G20210A) mutation, antithrombin III deficiency.
• Protein S (low levels outside of pregnancy) or Protein C deficiency.
• Hyperhomocysteinemia (due to safety concerns because n-3 may affect bleeding time).
• Hemophiliacs including von Willebrand's disease (because of safety concerns associated with the hemophilia treatment combined with the n-3 supplements).
• Planned termination of pregnancy.
• Current hypertension or current use of antihypertensive medication (including diuretics), due to increased risk of adverse pregnancy outcome.
• Pregestational diabetes due to increased risks of affecting fetal growth. We will not exclude women who develop GDM during pregnancy but consider a sub-analyses of these women depending on the number of subjects. Known maternal medical complications: cancer (including melanoma but excluding other skin cancers).
• Current hyperthyroidism if not adequately controlled.

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (3)

• Calabuig-Navarro V, Puchowicz M, Glazebrook P, Haghiac M, Minium J, Catalano P, Hauguel deMouzon S, O'Tierney-Ginn P. Effect of omega-3 supplementation on placental lipid metabolism in overweight and obese women. Am J Clin Nutr. 2016 Apr;103(4):1064-72. doi: 10.3945/ajcn.115.124651.

  PMID: 26961929 DERIVED

• Berggren EK, Groh-Wargo S, Presley L, Hauguel-de Mouzon S, Catalano PM. Maternal fat, but not lean, mass is increased among overweight/obese women with excess gestational weight gain. Am J Obstet Gynecol. 2016 Jun;214(6):745.e1-5. doi: 10.1016/j.ajog.2015.12.026. Epub 2015 Dec 21.

  PMID: 26719212 DERIVED

• Haghiac M, Yang XH, Presley L, Smith S, Dettelback S, Minium J, Belury MA, Catalano PM, Hauguel-de Mouzon S. Dietary Omega-3 Fatty Acid Supplementation Reduces Inflammation in Obese Pregnant Women: A Randomized Double-Blind Controlled Clinical Trial. PLoS One. 2015 Sep 4;10(9):e0137309. doi: 10.1371/journal.pone.0137309. eCollection 2015.

  PMID: 26340264 DERIVED

MeSH Terms

Conditions

Inflammation; Obesity; Metabolic Diseases; Insulin Resistance

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Patrick M Catalano, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

• Sylvie Hauguel-de Mouzon, PhD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Reproductive Biology

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2013
• Last Updated: May 3, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: when data analysis completed
• Access Criteria: when data analysis completed

Locations

US (1)