Micronutrient-supplemented Milk Study in Women of Childbearing Age

NCT ID: NCT01712165

Last Updated: 2013-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-10-31

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.

Conditions

Increase the Concentration of Folic Acid in Women of Childbearing Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

ANMUM Materna

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

Group Type: ACTIVE_COMPARATOR

ANMUM Materna

Intervention Type: DIETARY_SUPPLEMENT

Control

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

Group Type: PLACEBO_COMPARATOR

Control (milk powder)

Intervention Type: DIETARY_SUPPLEMENT

Interventions

ANMUM Materna

Intervention Type: DIETARY_SUPPLEMENT

Control (milk powder)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Changi General Hospital

OTHER

Sponsor Role: collaborator

Fonterra Research Centre

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magdalin Cheong

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Locations

Changi General Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

FON-ALTHEA-SG-2012-01

Identifier Type: -

Identifier Source: org_study_id