NCT01712165

Micronutrient-supplemented Milk Study in Women of Childbearing Age

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Fonterra Research Centre · Industry
• Sex: Female
• Age: 21 Years – 35 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ANMUM Materna
DIETARY_SUPPLEMENT	Control (milk powder)

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-10-23
• Last updated: 2013-10-11

Locations

1 site across 1 country: Singapore