N-3 Fatty Acid Requirements for Human Development

NCT00620672 | Completed Phase 1

• 2 other identifiers: H03-70242CW03-0084
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for humans, and are known to be important to reducing the risk of certain diseases, particularly those related to neural system, cardiovascular system and immune system. Among the different n-3 fatty acids, docosahexaenoic acid (DHA) is present in particularly high amounts in the brain and retina, and is accumulated in large amounts in these organs during the last trimester of fetal development and first few months after birth. The n-3 fatty acids are present in the diet as linolenic acid which is found in vegetable and seed oils, and as DHA which is only found in animal tissue fats, with fatty fish being the richest dietary source. Humans are able to convert linolenic acid to DHA, but the conversion is believed to be slow in human and possibly inadequate to support the needs for DHA for the developing brain. Information from our work and those of others has suggested that DHA is important during pregnancy, however specific evidence is lacking to show that the DHA status of pregnant women in low, or that improvement in the DHA status of Canadian women during pregnancy will have benefit to early infant an child development. There is no evidence that infants of vegans and vegetarians, or women who do not eat DHA are at risk for developmental delays. The purpose of this study is to investigate whether a dietary supplement of DHA during pregnancy has any effect on infant birth weight, or indices of infant growth, visual, mental and motor skill development.

Conditions

Pregnancy

Keywords

n-3 supplementation during pregnancy; DHA and pregnancy, infant development; n-3 status and gestation; DHA and visual acuity and cognition during infancy

Outcome Measures

Primary Outcomes (1)

• Primary outcome is measuring of infant CNS maturity to 18 months of age

  Primary outcome is measuring of infant CNS maturity to 18 months of age

  18 months

Secondary Outcomes (1)

• Length of gestation and infant birth weight, infant growth (weight, length and head circumference) at 1,2 6,9,12,14,and 18 months Language development at 14 and 16 months

  72 months

Study Arms (2)

1

OTHER

The dietary supplement is 400 mg/day of the omega 3 fatty acid docosahexaenoic acid . The docosahexaenoic acid is provided in triglycerides from Martek Biosciences, Maryland. The supplement is a blend of soybean and canola oil, blended to resemble the usual fat composition of the diet. Both the supplement and placebo provide a total of about 10 calories per day to the diet.

Dietary Supplement: omega 3 fatty acids

2

OTHER

Dietary supplement is vegetable oil, the placebo.

Dietary Supplement: vegetable oil

Interventions

omega 3 fatty acids DIETARY_SUPPLEMENT

The supplements are taken orally with a meal, each day. The amount of the omega 3 fatty acid docosahexaenoic acid is 400 mg/day; taken in two 500 mg capsules each providing 200 mg docosahexaenoic acid. The placebo is two 500 mg capsules soybean/canola oil. Both the supplement and placebo are a total of 1 gm/day (2x500 mg) and about 10 calories per day.

1

vegetable oil DIETARY_SUPPLEMENT

The supplement is a dietary supplement of vegetable oil as a placebo

2

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• weeks gestation
• Low risk pregnancy
• Expected to deliver single full term
• No maternal metabolic or infectious disease
• No known fetal complications.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Children's & Women's Health Centre of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (4)

• Mulder KA, King DJ, Innis SM. Omega-3 fatty acid deficiency in infants before birth identified using a randomized trial of maternal DHA supplementation in pregnancy. PLoS One. 2014 Jan 10;9(1):e83764. doi: 10.1371/journal.pone.0083764. eCollection 2014.

  PMID: 24427279 DERIVED

• Friesen RW, Innis SM. Linoleic acid is associated with lower long-chain n-6 and n-3 fatty acids in red blood cell lipids of Canadian pregnant women. Am J Clin Nutr. 2010 Jan;91(1):23-31. doi: 10.3945/ajcn.2009.28206. Epub 2009 Nov 18.

  PMID: 19923368 DERIVED

• Friesen RW, Innis SM. Dietary arachidonic acid to EPA and DHA balance is increased among Canadian pregnant women with low fish intake. J Nutr. 2009 Dec;139(12):2344-50. doi: 10.3945/jn.109.112565. Epub 2009 Oct 28.

  PMID: 19864401 DERIVED

• van Dijk CE, Innis SM. Growth-curve standards and the assessment of early excess weight gain in infancy. Pediatrics. 2009 Jan;123(1):102-8. doi: 10.1542/peds.2007-3382.

  PMID: 19117867 DERIVED

MeSH Terms

Interventions

Fatty Acids, Omega-3; Plant Oils

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Sheila M. Innis, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: May 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

CA (1)