Increase the Concentration of Folic Acid in Women of Childbearing Age
Conditions
Keywords
Folic acid supplement, Neural tube defect-affected pregnancy, Homocysteine concentration, Plasma Folate concentration, Plasma vitamin B12 concentration
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTANMUM Materna
DIETARY_SUPPLEMENTControl (milk powder)
Sponsors
Changi General Hospital
Fonterra Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Female 21-35 years old. * Able to understand the nature and purpose of the study, including potential risks and side effects. * Willing to consent to study participation and to comply with study requirements. * Negative Pregnancy test at screening
Exclusion criteria
* Consumption of vitamins and/or mineral supplements known to contain folate 6 months prior. * Chronic disease. * Milk and/or lactose-intolerant. * Pregnancy in the last 12 months, or currently planning a pregnancy. * Prior history of NTD-affected pregnancy * Serum Folate deficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in red blood cell folate concentration | 12 weeks | To determine if consuming ANMUM Materna 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in homocysteine concentration | 12 weeks | To determine if consuming ANMUM Materna over a 12-week period lowers homocysteine concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk. |
| Increase in plasma folate concentration | 12 weeks | To determine if consuming ANMUM Materna over a 12-week period increases plasma folate concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk. |
| Increase in plasma vitamin B12 concentration | 12 weeks | To determine if consuming ANMUM over a 12-week period increases plasma vitamin B12 concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk. |
Countries
Singapore
Outcome results
None listed