Zielinsky 2015.
Trial name or title | Effect of mother's supplementation omega‐3 in the dynamics of fetal ductus arteriosus: a randomized clinical trial |
Methods | RCT: NCT02565290 |
Participants |
Recruitment target: 74 women. Inclusion criteria: at 28‐32 weeks' gestation; and willing to participate Exclusion criteria: hypertensive; diabetic; not using anti‐inflammatory drugs; not HIV positive; not using mate, black or green tea; no inflammation in past 5 days; and not allergic to fish or soy. Setting: Brazil |
Interventions |
Intervention group Omega 3 capsules (1g), 2 times a day, for 21 days. Control group Placebo soy oil capsules (1g), 2 times a day, for 21 days. |
Outcomes |
Primary outcome: pulsatility index of fetal ductus arteriosus Other outcomes: inflammatory biomarkers (interleukins, prostaglandins, cyclooxygenase); systolic and diastolic velocity of fetal ductus arteriosus; and biomarkers of oxidative stress. |
Starting date | May 2015 |
Contact information | Dr Paulo Zielinsky, Instituto de Cardiologia do Rio Grande do Sul. E‐mail: paulozie.voy@terra.com.br |
Notes | Funding and collaborators: Instituto de Cardiologia do Rio Grande do Sul. |