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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01413776

Enrollment

547

Registered

2011-08-10

Start date

2011-08-31

Completion date

2013-03-31

Last updated

2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal and Newborn Health

Brief 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.

Interventions

DIETARY_SUPPLEMENTCorn 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Mean birth weight	9 months

Secondary

Measure	Time frame
Mean gestational weight gain	9 months
Mean maternal hemoglobin level	9 months
Mean birth length and head circumference	9 months

Countries

Cambodia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026