Clinical trial NCT01712165: Micronutrient-supplemented Milk Study in Women of Childbearing Age
Official title: Micronutrient-supplemented Milk Study in Women of Childbearing Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increase the Concentration of Folic Acid in Women of Childbearing Age
Keywords: Folic acid supplement
Neural tube defect-affected pregnancy
Homocysteine concentration
Plasma Folate concentration
Plasma vitamin B12 concentration
Lead sponsor: Fonterra Research Centre
Sponsor class: INDUSTRY
Collaborators: name: Changi General Hospital
First posted: 2012-10-23
Enrollment: 70
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Increase in red blood cell folate concentration
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction in homocysteine concentration
timeFrame: 12 weeks
measure: Increase in plasma folate concentration
timeFrame: 12 weeks
measure: Increase in plasma vitamin B12 concentration
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Magdalin Cheong
role: PRINCIPAL_INVESTIGATOR
References: