Martini 2014 (CORDHA).
Trial name or title | A randomised controlled trial for the optimization of the viability of stem cells derived from umbilical CORd blood after maternal supplementation with DHA during the second or third trimester of pregnancy (CORDHA) |
Methods | RCT: ISRCTN58396079. |
Participants |
Recruitment target: 150 women. Inclusion criteria: Caucasian, non‐smoker, > 18 years of age, single pregnancy, absence of diabetes or hypertension or any other type of pathology requiring pharmacological therapy, absence of chromosome abnormalities and/or congenital malformations in the fetus, and HBV, HCV, HIV and CMV negative. Exclusion criteria: impossible to collect cord blood (for bureaucratic reasons or because of emergencies regarding the health of the mother or the baby), taken other supplements containing DHA or fish oil, temperature of 39C during birth, and UCB samples with a volume of less than 80 mL and/or less than 70% cell vitality. Setting: Rome, Italy. |
Interventions |
Intervention group DHA (250 mg/day), from the 20th or from the 28th week up to the 40th week of estimated gestational age. Control group Placebo (250 mg olive oil/day), from the 20th or from the 28th week up to the 40th week of estimated gestational age. |
Outcomes |
Primary outcome: measure of the viability (%) and the number of CD34+ cells collected from the umbilical cord blood at birth. No other outcomes specified. |
Starting date | September 2010 |
Contact information | Irene Martini, Via Vittorio Locchi 9 00197 Rome, Italy. E‐mail: martini@smartbank.it |
Notes |
Funding and collaborators: SmartBank SRL; Biovault and Avantgarde SAS. Recruitment ended September 2014. |