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

University of British Columbia

Status: Completed

Conditions: Maternal and Newborn Health

Treatments: Dietary Supplement: Corn Soya Blend+

Study type: Interventional

Funder types: Other

Identifiers

NCT01413776

H11-00801

Details and patient eligibility

About

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.

Enrollment: 547 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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547 participants in 2 patient groups

Dietary supplement

Experimental group

Description:

Pregnant women in 37 villages.

Treatment:

Dietary Supplement: Corn Soya Blend+

Control group

No Intervention group

Description:

Pregnant women in 38 villages