DHA Supplementation and Pregnancy Outcome

Study Overview
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Brief Summary
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Supplementation with DHA during pregnancy will increase gestational length and improve cognitive development.

Detailed Description
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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.

Official Title
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Maternal DHA Supplementation and Pregnancy Outcome

Conditions
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Pregnancy

Intervention / Treatment
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* Dietary Supplement: 600 mg DHA
* Dietary Supplement: 300 mg DHA
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 300 mg DHA<br>300 mg DHA | Dietary Supplement: 300 mg DHA<br>* Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding<br>|
| Placebo Comparator: Placebo<br>olive oil or high oleic acid sunflower oil placebo | Dietary Supplement: Placebo<br>* Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period<br>|
| Experimental: 600 mg DHA<br>600 mg DHA | Dietary Supplement: 600 mg DHA<br>* Pregnant women were given 600 mg DHA in the last trimester of pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Length | Length of gestation as measured by Last menstrual period method and US | 13 weeks | 
| Cognitive Development | Bayley's Scales of Infant Development measured at 4 months of age | 4 months | 
| Cognitive Development | Bayley's Scales of Infant Development measured at 12 months of age | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant birth length | self-explanatory | 13 weeks | 
| Infant Growth Velocity | Change in infant length and weight from 2 to 4 months of age | 2 months to 4 months of age | 
| Infant birth weight | self-explanatory | 13 weeks | 
| Infant head circumference at birth | self-explanatory | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, DHA, Gestational Length, Cognitive Development