Increase the Concentration of Folic Acid in Women of Childbearing Age Clinical Trial
Official title:
Micronutrient-supplemented Milk Study in Women of Childbearing Age
The purpose of this study is to determine if consuming ANMUM Materna (a fortified milk product) over a 12-week period increases red blood cell folate concentrations in women of childbearing age in Singapore, compared to an equivalent amount of standard (unfortified) milk.
Folic acid (~400 µg/day) taken around the time of conception significantly reduces the risk
of a neural tube defect (NTD)-affected pregnancy. Strategies to reduce NTD with folic acid,
include supplement use and food fortification. An attractive strategy for NTD prevention is
the use of fortified foods targeted for use by women planning a pregnancy. Fonterra
currently markets a fortified-milk (ANMUM Materna) in Asia, designed for use prior to and
during pregnancy. This milk product, if consumed as directed, provides ~400 µg folic acid
per day. It is not known whether ANMUM Materna will reduce NTD rate. However, in a
case-control study the risk of NTD was inversely associated with maternal red blood cell
(RBC) folate concentrations. Accordingly, if ANMUM Materna increases RBC folate, it could be
expected to decrease NTD risk.
In this study, the ANMUM Materna fortified milk will be tested against a standard control
(unfortified) milk over a 12 week period. The subjects will consume 75g of milk powder daily
throughout the supplementation period.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research