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

NCT01353807 | Completed DMC

• 2 other identifiers: M-AA-20060182R21AT004603
• Study Type: interventional
• Target: 533
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Delivery; Atopy; Metabolic Syndrome

Keywords

Fish oil; Pregnancy; RCT; Birth weight; Gestational age; Asthma and allergies; Metabolic syndrome; Obesity

Outcome Measures

Primary Outcomes (1)

• Gestation length

  We assesed impact of fish oil supplementation in pregnancy on timing of spontaneous delivery

  1989-1990 (1 year)

Study Arms (3)

Fish oil supplementation

ACTIVE COMPARATOR

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

Dietary Supplement: Fish oil

Olive oil

PLACEBO COMPARATOR

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

Dietary Supplement: Olive oil

No oil supplement

NO INTERVENTION

These women received no capsules with oil

Interventions

Fish oil DIETARY_SUPPLEMENT

4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids

Also known as: Pikasol

Fish oil supplementation

Olive oil DIETARY_SUPPLEMENT

4 1-g gelatine capsules with virgin olive oil

Olive oil

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women in gestation week 30

You may not qualify if:

• Bleeding episodes during pregnancy

Sponsors & Collaborators

• Centre for Fetal Programming, Denmark: lead
• National Institutes of Health (NIH): collaborator
• The Danish Council for Strategic Research: collaborator
• Danish Council for Independent Research: collaborator
• Lundbech Foundation: collaborator
• EU Commision, DG12: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, DK-8000, Denmark

Location

Related Publications (5)

• Olsen SF, Sorensen JD, Secher NJ, Hedegaard M, Henriksen TB, Hansen HS, Grant A. Randomised controlled trial of effect of fish-oil supplementation on pregnancy duration. Lancet. 1992 Apr 25;339(8800):1003-7. doi: 10.1016/0140-6736(92)90533-9.

  PMID: 1349049 RESULT

• Olsen SF, Osterdal ML, Salvig JD, Mortensen LM, Rytter D, Secher NJ, Henriksen TB. Fish oil intake compared with olive oil intake in late pregnancy and asthma in the offspring: 16 y of registry-based follow-up from a randomized controlled trial. Am J Clin Nutr. 2008 Jul;88(1):167-75. doi: 10.1093/ajcn/88.1.167.

  PMID: 18614738 RESULT

• Rytter D, Bech BH, Christensen JH, Schmidt EB, Henriksen TB, Olsen SF. Intake of fish oil during pregnancy and adiposity in 19-y-old offspring: follow-up on a randomized controlled trial. Am J Clin Nutr. 2011 Sep;94(3):701-8. doi: 10.3945/ajcn.111.014969. Epub 2011 Jul 20.

  PMID: 21775563 RESULT

• Rytter D, Schmidt EB, Bech BH, Christensen JH, Henriksen TB, Olsen SF. Fish oil supplementation during late pregnancy does not influence plasma lipids or lipoprotein levels in young adult offspring. Lipids. 2011 Dec;46(12):1091-9. doi: 10.1007/s11745-011-3606-5. Epub 2011 Aug 27.

  PMID: 21874272 RESULT

• Rytter D, Christensen JH, Bech BH, Schmidt EB, Henriksen TB, Olsen SF. The effect of maternal fish oil supplementation during the last trimester of pregnancy on blood pressure, heart rate and heart rate variability in the 19-year-old offspring. Br J Nutr. 2012 Oct 28;108(8):1475-83. doi: 10.1017/S0007114511006799. Epub 2012 Feb 7.

  PMID: 22313729 RESULT

Related Links

• Protocol and correspondences

MeSH Terms

Conditions

Premature Birth; Metabolic Syndrome; Birth Weight; Asthma; Hypersensitivity; Obesity

Interventions

Fish Oils; Pikasol; Olive Oil

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sjurdur F. Olsen, MD

  Statens Serum Institut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 16, 2011
• Study Start: November 1, 1989
• Primary Completion: December 1, 1990
• Study Completion: May 1, 2011
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

DK (1)