Status:
NOT_YET_RECRUITING
Effect of Folic Acid Supplementation in Pregnant Women Having Thalassaemia Trait
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Queen Mary Hospital, Hong Kong
Conditions:
Thalassemia
Folic Acid Deficiency Anemia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Folic acid supplementation is well established for its role in prevention of neural tube defects (NTD) when taken periconceptionally up to 12 weeks of gestation. The naturally occurring form, folate, ...
Eligibility Criteria
Inclusion
- Singleton pregnancy
- Alpha thalassaemia trait
- Beta thalassaemia trait
Exclusion
- 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
- Serum ferritin level \< 30ug/L or 68 pmol/L
- Concomitant alpha and beta thalassaemia
- Hb H disease
- Beta thalassaemia major
- Beta thalassaemia intermediate
- Thalassaemia other than alpha or beta type
- Women on long term medications
- Women with risk factors for NTD
- Women with known epilepsy
- Women with bariatric surgery or malabsorption diseases
- Women with known MTHFR polymorphism
- Vegetarian
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04310059
Start Date
July 1 2024
End Date
July 31 2026
Last Update
November 29 2023
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