DHA Supplementation and Pregnancy Outcome

Pregnancy Clinical Trial

Official title:

Maternal DHA Supplementation and Pregnancy Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219399
• Other study ID #: 00186H
• Status: Completed
• Phase: N/A
• First received: June 9, 2014
• Last updated: August 15, 2014
• Start date: January 2001
• Est. completion date: January 2014

Study information

• Verified date: August 2014
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Supplementation with DHA during pregnancy will increase gestational length and improve cognitive development.

Description:

This was a trial of supplementation with DHA during pregnancy to increase gestational length. Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data were collected and infants growth at 2 and 4 months and cognitive development at 4 months and 1 year were measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 871
• Est. completion date: January 2014
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• singleton pregnancy

• 18 years of age or older

Exclusion Criteria:

• cervical incompetence

• presence of cervical cerclage

• placenta previa

• intrauterine infection

• known substance abuse

• multiple fetuses

• current pre-eclampsia

• preexisting diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Pregnancy

Intervention

Dietary Supplement:
• 600 mg DHA
Pregnant women were given 600 mg DHA in the last trimester of pregnancy
• 300 mg DHA
Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding
• Placebo
Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period

Locations

Country	Name	City	State
United States	Denver Health Hospitals and Clinics	Denver	Colorado
United States	Colorado State University	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado State University	USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational Length	Length of gestation as measured by Last menstrual period method and US	13 weeks	No
Primary	Cognitive Development	Bayley's Scales of Infant Development measured at 4 months of age	4 months	No
Primary	Cognitive Development	Bayley's Scales of Infant Development measured at 12 months of age	12 months	No
Secondary	Infant birth length	self-explanatory	13 weeks	No
Secondary	Infant Growth Velocity	Change in infant length and weight from 2 to 4 months of age	2 months to 4 months of age	No
Secondary	Infant birth weight	self-explanatory	13 weeks	No
Secondary	Infant head circumference at birth	self-explanatory	13 weeks	No