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Micronutrient-supplemented Milk Study in Women of Childbearing Age

This study is not yet open for participant recruitment.
Verified May 2013 by Fonterra Research Centre
Sponsor:
Collaborator:
Changi General Hospital
Information provided by (Responsible Party):
Fonterra Research Centre
ClinicalTrials.gov Identifier:
NCT01712165
First received: October 19, 2012
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Increase the Concentration of Folic Acid in Women of Childbearing Age
 Dietary Supplement: ANMUM Materna
Dietary Supplement: Control (milk powder)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Micronutrient-supplemented Milk Study in Women of Childbearing Age

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Further study details as provided by Fonterra Research Centre:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 70
Study Start Date: June 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ANMUM Materna
75g milk powder in 400 ml water daily for 12 weeks.
 Dietary Supplement: ANMUM Materna
Placebo Comparator: Control
75g of milk powder in 400 ml water for 12 weeks.
 Dietary Supplement: Control (milk powder)

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

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712165

Contacts
Contact: Magdalin Cheong +65 67888833 magdalin_cheong@cgh.com.sg

Locations
Singapore
Changi General Hospital Not yet recruiting
Singapore, Singapore, 529889
Contact: Magdalin Cheong     +65 67888833     magdalin_cheong@cgh.com.sg    
Principal Investigator: Magdalin Cheong            
Sponsors and Collaborators
Fonterra Research Centre
Changi General Hospital
Investigators
Principal Investigator: Magdalin Cheong Changi General Hospital
  More Information

No publications provided

Responsible Party: Fonterra Research Centre
ClinicalTrials.gov Identifier: NCT01712165     History of Changes
Other Study ID Numbers: FON-ALTHEA-SG-2012-01
Study First Received: October 19, 2012
Last Updated: May 10, 2013
Health Authority: Singapore: Institutional Review Board

Keywords provided by Fonterra Research Centre:
Folic acid supplement
Neural tube defect-affected pregnancy
Homocysteine concentration
Plasma Folate concentration
Plasma vitamin B12 concentration

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013