Micronutrient-supplemented Milk Study in Women of Childbearing Age

Fonterra

Status: Completed

Conditions: Increase the Concentration of Folic Acid in Women of Childbearing Age

Treatments: Dietary Supplement: Control (milk powder); Dietary Supplement: ANMUM Materna

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01712165

FON-ALTHEA-SG-2012-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

ANMUM Materna

Active Comparator group

Description:

75g milk powder in 400 ml water daily for 12 weeks.

Treatment:

Dietary Supplement: ANMUM Materna

Control

Placebo Comparator group

Description:

75g of milk powder in 400 ml water for 12 weeks.

Treatment:

Dietary Supplement: Control (milk powder)