NCT01712165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 11, 2013

Status Verified

October 1, 2013

Enrollment Period

4 months

First QC Date

October 19, 2012

Last Update Submit

October 10, 2013

Conditions

Increase the Concentration of Folic Acid in Women of Childbearing Age

Keywords

Folic acid supplementNeural tube defect-affected pregnancyHomocysteine concentrationPlasma Folate concentrationPlasma vitamin B12 concentration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Reduction in homocysteine concentration

    12 weeks

  • Increase in plasma folate concentration

    12 weeks

  • Increase in plasma vitamin B12 concentration

    12 weeks

Study Arms (2)

ANMUM Materna

ACTIVE COMPARATOR

75g milk powder in 400 ml water daily for 12 weeks.

Dietary Supplement: ANMUM Materna

Control

PLACEBO COMPARATOR

75g of milk powder in 400 ml water for 12 weeks.

Dietary Supplement: Control (milk powder)

Interventions

ANMUM MaternaDIETARY_SUPPLEMENT
ANMUM Materna
Control (milk powder)DIETARY_SUPPLEMENT
Control

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Study Officials

  • Magdalin Cheong

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2012

First Posted

October 23, 2012

Study Start

June 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 11, 2013

Record last verified: 2013-10

Locations

SG(1)