Micronutrient-supplemented Milk Study in Women of Childbearing Age

Increase the Concentration of Folic Acid in Women of Childbearing Age Clinical Trial

Official title:

Micronutrient-supplemented Milk Study in Women of Childbearing Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712165
• Other study ID #: FON-ALTHEA-SG-2012-01
• Status: Completed
• Phase: N/A
• First received: October 19, 2012
• Last updated: October 10, 2013
• Start date: June 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Fonterra Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Increase the Concentration of Folic Acid in Women of Childbearing Age

Intervention

Dietary Supplement:
• ANMUM Materna

• Control (milk powder)

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Fonterra Research Centre	Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No