Increase the Concentration of Folic Acid in Women of Childbearing AgeNCT01712165
Micronutrient-supplemented Milk Study in Women of Childbearing Age
A study testing ANMUM Materna in people with Increase the Concentration of Folic Acid in Women of Childbearing Age, run by Fonterra Research Centre at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Increase the Concentration of Folic Acid in Women of Childbearing Age
- What is being tested?
- ANMUM Materna
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- ANMUM Materna, Control (milk powder)
- Keywords
- Folic acid supplement, Neural tube defect-affected pregnancy, Homocysteine concentration, Plasma Folate concentration, Plasma vitamin B12 concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANMUM MaternaDietary supplement
Control (milk powder)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| ANMUM Materna | Active comparator | 75g milk powder in 400 ml water daily for 12 weeks. Receives: Dietary Supplement: ANMUM Materna |
| Control | Placebo comparator | 75g of milk powder in 400 ml water for 12 weeks. Receives: Dietary Supplement: Control (milk powder) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increase the Concentration of Folic Acid in Women of Childbearing AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fonterra Research Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Changi General Hospital
- Responsible party
- Sponsor
- Investigators
- Magdalin Cheong, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712165
- Sponsor's protocol ID
- FON-ALTHEA-SG-2012-01
- Status last verified
- Oct 2013
- First submitted
- 19 Oct 2012
- Last updated
- 11 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronutrient-supplemented Milk Study in Women of Childbearing Age
- ClinicalTrials.gov ID
- NCT01712165
- Acronym / sponsor ID
- FON-ALTHEA-SG-2012-01
- Keywords
- Folic acid supplement, Neural tube defect-affected pregnancy, Homocysteine concentration, Plasma Folate concentration, Plasma vitamin B12 concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fonterra Research CentreIndustry (pharma, biotech, devices)
- Collaborators
- Changi General Hospital
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANMUM Materna | Active comparator | Dietary Supplement: ANMUM Materna75g milk powder in 400 ml water daily for 12 weeks. |
| Control | Placebo comparator | Dietary Supplement: Control (milk powder)75g of milk powder in 400 ml water for 12 weeks. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANMUM Materna | Dietary supplement | ANMUM Materna |
| Control (milk powder) | Dietary supplement | Control |
Primary outcome
Increase in red blood cell folate concentration
Time frame: 12 weeks
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.
3 secondary outcomes
Reduction in homocysteine concentration
Time frame: 12 weeks
Increase in plasma folate concentration
Time frame: 12 weeks
Increase in plasma vitamin B12 concentration
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalin Cheong principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANMUM Materna in people with Increase the Concentration of Folic Acid in Women of Childbearing Age, run by Fonterra Research Centre at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in red blood cell folate concentration (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2013.