Maternal and Newborn HealthNCT01413776
Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
A study testing Corn Soya Blend+ in people with Maternal and Newborn Health, run by University of British Columbia at 1 site in Cambodia.
Trial summary
The study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal and Newborn Health
- What is being tested?
- Corn Soya Blend+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 547 participants
- Where
- 1 siteCambodia
- Study dates
- Aug 2011to Mar 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 18 years of age
- in first trimester of pregnancy
- plans to reside in the same village during the entire pregnancy
Who cannot join
- a minor
- not in first trimester of pregnancy
- plans to relocate during the pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not.
- Conditions
- Maternal and Newborn Health
- Being tested
- Corn Soya Blend+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corn Soya Blend+Dietary supplement
A blended food consisting of corn (75-80%) and soybeans (20-25%) that has been fortified with a premix of 19 vitamins and minerals.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement | Experimental | Pregnant women in 37 villages. Receives: Dietary Supplement: Corn Soya Blend+ |
| Control group | No intervention | Pregnant women in 38 villages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean birth weight
Measured: 9 months
Secondary outcomes (3)
Mean gestational weight gain
Measured: 9 months
Mean maternal hemoglobin level
Measured: 9 months
Mean birth length and head circumference
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal and Newborn HealthStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- International Relief and Development
- Responsible party
- Sponsor
- Investigators
- Judy McLean, Dr., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413776
- Sponsor's protocol ID
- H11-00801
- Status last verified
- Mar 2014
- First submitted
- 9 Aug 2011
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Janmohamed A, Karakochuk CD, Boungnasiri S, Chapman GE, Janssen PA, Brant R, Green TJ, McLean J. Prenatal supplementation with Corn Soya Blend Plus reduces the risk of maternal anemia in late gestation and lowers the rate of preterm birth but does not significantly improve maternal weight gain and birth anthropometric measurements in rural Cambodian women: a randomized trial. Am J Clin Nutr. 2016 Feb;103(2):559-66. doi: 10.3945/ajcn.114.104034. Epub 2016 Jan 6.
PubMed 26739037Janmohamed A, Karakochuk CD, Boungnasiri S, Whitfield KC, Chapman GE, Janssen P, McLean J, Green TJ. Factors affecting the acceptability and consumption of Corn Soya Blend Plus as a prenatal dietary supplement among pregnant women in rural Cambodia. Public Health Nutr. 2016 Jul;19(10):1842-51. doi: 10.1017/S1368980015003018. Epub 2015 Oct 16.
PubMed 26471409
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
- ClinicalTrials.gov ID
- NCT01413776
- Acronym / sponsor ID
- H11-00801
- Conditions
- Maternal and Newborn Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- International Relief and Development
- Study start
- Aug 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 Aug 2011 (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 study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Experimental | Dietary Supplement: Corn Soya Blend+Pregnant women in 37 villages. |
| Control group | No intervention | –Pregnant women in 38 villages |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- at least 18 years of age
- in first trimester of pregnancy
- plans to reside in the same village during the entire pregnancy
Key exclusion criteria (3 listed)
- a minor
- not in first trimester of pregnancy
- plans to relocate during the 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 |
|---|---|---|
| Corn Soya Blend+A blended food consisting of corn (75-80%) and soybeans (20-25%) that has been fortified with a premix of 19 vitamins and minerals. | Dietary supplement | Dietary supplement |
Primary outcome
Mean birth weight
Time frame: 9 months
3 secondary outcomes
Mean gestational weight gain
Time frame: 9 months
Mean maternal hemoglobin level
Time frame: 9 months
Mean birth length and head circumference
Time frame: 9 months
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 17 Mar 2014.
- Derived from this study: PubMed 26739037Janmohamed A, Karakochuk CD, Boungnasiri S, Chapman GE, Janssen PA, Brant R, Green TJ, McLean J. Prenatal supplementation with Corn Soya Blend Plus reduces the risk of maternal anemia in late gestation and lowers the rate of preterm birth but does not significantly improve maternal weight gain and birth anthropometric measurements in rural Cambodian women: a randomized trial. Am J Clin Nutr. 2016 Feb;103(2):559-66. doi: 10.3945/ajcn.114.104034. Epub 2016 Jan 6.
- Derived from this study: PubMed 26471409Janmohamed A, Karakochuk CD, Boungnasiri S, Whitfield KC, Chapman GE, Janssen P, McLean J, Green TJ. Factors affecting the acceptability and consumption of Corn Soya Blend Plus as a prenatal dietary supplement among pregnant women in rural Cambodia. Public Health Nutr. 2016 Jul;19(10):1842-51. doi: 10.1017/S1368980015003018. Epub 2015 Oct 16.
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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.
Judy McLean, Dr. principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corn Soya Blend+ in people with Maternal and Newborn Health, run by University of British Columbia at 1 site in Cambodia.
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 3 inclusion and 3 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 17 Mar 2014. 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 Cambodia. 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. 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?
Mean birth weight (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01413776, which also lists 2 linked publications.
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 17 Mar 2014.