About this trial
Folic acid supplementation has been recommended for prevention of neural tube defects in pregnancy when taken periconceptionally up to 12 weeks of gestation. A daily dose of 0.4mg has been endorsed by World Health Organisation to achieve a Red blood cell (RBC) folate level of 906nmol/L (400ng/mL) for reduction of neural tube defect. Hong Kong has no policy on food fortification. Research data conducted in countries with food fortification may not be applicable. It is therefore essential to study the baseline folate status in pregnant women locally.
For pregnant women with thalassaemia, they are believed to have a higher risk of folate deficiency because of an increased rate of erythropoiesis and chronic haemolysis. However, information on folate level of thalassaemia trait in pregnancy is scanty. Unmetabolized folic acid has been detected in maternal and fetal blood when daily dosage greater than 0.8-1mg was taken. In term of the dosage and duration of folic acid supplementation after 12 weeks of gestation, the practice varies widely among public hospitals and Maternity \& Child Health Care centres. It is therefore essential to study the optimal dosage of folic acid supplementation in women with thalassaemia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Singleton pregnancy
Alpha thalassaemia trait
Beta thalassaemia trait
Disqualifiers
Women taking over 0.6mg folic acid daily for 3 months or more prior to and during pregnancy
Gestational age > 16 weeks at first antenatal visit
Women age =< 18 years old
Booking BMI =< 18 or >= 35
Trial design
Parallel
Treatments tested in this trial
Folic acid
Dietary supplementwomen will be randomised into one of the three groups. Group A - Folic acid 5mg/day Group B - Folic acid 0.5mg/day Group C - Materna one tablet/day (a pregnancy supplement containing 0.6mg folic acid)
Materna
Dietary supplementMaterna
Treatment groups
Trial outcomes
Primary outcomes
Haemoglobin level
Maternal RBC folate concentration
Maternal serum folate concentration
Cord blood RBC
Secondary outcomes
Ferritin level
Maternal Vitamin B12
Cord blood vitamin B12
Locations
Sponsors and contacts
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The University of Hong Kong
Lead sponsor
Queen Mary Hospital, Hong Kong
Collaborator
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