Micronutrient-supplemented Milk Study in Women of Childbearing Age

This study has been completed.
Sponsor:
Collaborator:
Changi General Hospital
Information provided by (Responsible Party):
Fonterra Research Centre
ClinicalTrials.gov Identifier:
NCT01712165
First received: October 19, 2012
Last updated: October 10, 2013
Last verified: October 2013

October 19, 2012
October 10, 2013
June 2013
October 2013   (final data collection date for primary outcome measure)
Increase in red blood cell folate concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01712165 on ClinicalTrials.gov Archive Site
  • Reduction in homocysteine concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Micronutrient-supplemented Milk Study in Women of Childbearing Age
Micronutrient-supplemented Milk Study in Women of Childbearing Age

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Increase the Concentration of Folic Acid in Women of Childbearing Age
  • Dietary Supplement: ANMUM Materna
  • Dietary Supplement: Control (milk powder)
  • Active Comparator: ANMUM Materna
    75g milk powder in 400 ml water daily for 12 weeks.
    Intervention: Dietary Supplement: ANMUM Materna
  • Placebo Comparator: Control
    75g of milk powder in 400 ml water for 12 weeks.
    Intervention: Dietary Supplement: Control (milk powder)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Female
21 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01712165
FON-ALTHEA-SG-2012-01
No
Fonterra Research Centre
Fonterra Research Centre
Changi General Hospital
Principal Investigator: Magdalin Cheong Changi General Hospital
Fonterra Research Centre
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP