Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia

NCT ID: NCT01413776

Last Updated: 2014-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

547 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Maternal and Newborn Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dietary supplement

Pregnant women in 37 villages.

Group Type EXPERIMENTAL

Corn Soya Blend+

Intervention Type 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.

Control group

Pregnant women in 38 villages

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age
* in first trimester of pregnancy
* plans to reside in the same village during the entire pregnancy

Exclusion Criteria

* a minor
* not in first trimester of pregnancy
* plans to relocate during the pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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International Relief and Development

UNKNOWN

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judy McLean, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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4 Health Centers

Kampong Chhnang, , Cambodia

Site Status

Countries

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Cambodia

References

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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.

Reference Type DERIVED
PMID: 26739037 (View on PubMed)

Janmohamed 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.

Reference Type DERIVED
PMID: 26471409 (View on PubMed)

Other Identifiers

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H11-00801

Identifier Type: -

Identifier Source: org_study_id

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