Micronutrient-supplemented Milk Study in Women of Childbearing Age

Fonterra Research Centre70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Increase the Concentration of Folic Acid in Women of Childbearing Age

Interventions

ANMUM MaternaDIETARY_SUPPLEMENT

Control (milk powder)DIETARY_SUPPLEMENT

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Changi General Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

Increase in red blood cell folate concentration

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.

Time frame: 12 weeks

Secondary Outcomes

Reduction in homocysteine concentration

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.

Time frame: 12 weeks

Increase in plasma folate concentration

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.

Time frame: 12 weeks

Increase in plasma vitamin B12 concentration

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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