Micronutrient-supplemented Milk Study in Women of Childbearing Age

Not Applicable

Completed

• Conditions: Increase the Concentration of Folic Acid in Women of Childbearing Age
• Interventions: Dietary Supplement: ANMUM Materna; Dietary Supplement: Control (milk powder)

• Registration Number: NCT01712165
• Lead Sponsor: Fonterra Research Centre

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.

Study Timeline

• Study First Submitted: 2012-10-19
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-23
• Study Start: 2013-06
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANMUM Materna	ANMUM Materna	75g milk powder in 400 ml water daily for 12 weeks.
Control	Control (milk powder)	75g of milk powder in 400 ml water for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Increase in red blood cell folate concentration	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Reduction in homocysteine concentration	12 weeks	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.
Increase in plasma folate concentration	12 weeks	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.
Increase in plasma vitamin B12 concentration	12 weeks	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.

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore