Effect of Folic Acid Supplementation in Pregnant Women Having Thalassaemia Trait

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Folic acid

    Dietary supplement

    women 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 supplement

    Materna

Treatment groups

270 Participants
are divided into 3 treatment groups
Group A: Folic acid 5mgActive comparator 1 intervention
Group B: Folic acid 0.5mgActive comparator 1 intervention
Group C: MaternaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Haemoglobin level

Time frame
Change in level throughout the pregnancy, up to 42 weeks
2

Maternal RBC folate concentration

Time frame
Change in level throughout the pregnancy, up to 42 weeks
3

Maternal serum folate concentration

Time frame
Change in level throughout the pregnancy, up to 42 weeks
4

Cord blood RBC

Time frame
Upon birth

Secondary outcomes

1

Ferritin level

Time frame
Change in level throughout the pregnancy, up to 42 weeks
2

Maternal Vitamin B12

Time frame
Maternal Vitamin B12 at first antenatal visit
3

Cord blood vitamin B12

Time frame
Cord blood vitamin B12 upon birth

Other outcomes

Locations

This trial has no 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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