Micronutrient-supplemented Milk Study in Women of Childbearing Age

Study Overview
=================
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.

Official Title
-----------------
Micronutrient-supplemented Milk Study in Women of Childbearing Age

Conditions
-----------------
Increase the Concentration of Folic Acid in Women of Childbearing Age

Intervention / Treatment
-----------------
* Dietary Supplement: ANMUM Materna
* Dietary Supplement: Control (milk powder)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ANMUM Materna<br>75g milk powder in 400 ml water daily for 12 weeks. | Dietary Supplement: ANMUM Materna<br> <br> |
| Placebo Comparator: Control<br>75g of milk powder in 400 ml water for 12 weeks. | Dietary Supplement: Control (milk powder)<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Folic acid supplement, Neural tube defect-affected pregnancy, Homocysteine concentration, Plasma Folate concentration, Plasma vitamin B12 concentration