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.

Study Overview

• Status: Completed
• Conditions: Increase the Concentration of Folic Acid in Women of Childbearing Age
• Intervention / Treatment: Dietary supplement: ANMUM Materna; Dietary supplement: Control (milk powder)

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ANMUM Materna; 75g milk powder in 400 ml water daily for 12 weeks.	Dietary supplement: ANMUM Materna
PLACEBO_COMPARATOR: Control; 75g of milk powder in 400 ml water for 12 weeks.	Dietary supplement: Control (milk powder)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: Fonterra Research Centre
• Collaborators: Changi General Hospital
• Investigators: Principal Investigator: Magdalin Cheong, Changi General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: October 19, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (ESTIMATE): October 23, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2013
• Last Update Submitted That Met QC Criteria: October 10, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Folic acid supplement; Neural tube defect-affected pregnancy; Homocysteine concentration; Plasma Folate concentration; Plasma vitamin B12 concentration
• Other Study ID Numbers: FON-ALTHEA-SG-2012-01