Protein Supplementation of Snakehead Fish Cookies on Pregnant Women

NCT ID: NCT04265391

Last Updated: 2020-02-11

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-03

Study Completion Date

2019-12-02

Brief Summary

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This study was randomized controlled trial study whose subjects were pregnant women in Sleman District, Yogyakarta, Indonesia. The aims of this study were to make snakehead fish cookies formula which can be well accepted by pregnant women and to observed its effect on fetal growth and birth weight and length. It was hypothesized that snakehead fish cookies could prevent intrauterine fetal growth (IUGR) and low birth weight (LBW).

Subjects on this study were randomly allocated into two groups which were treatment and control group. Subjects in treatment group were given snakehead fish cookies, while subject in control group received standard cookies. The intervention period lasted until subjects delivered their babies.

Detailed Description

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Subjects were enrolled from Public Health Center (puskesmas) in Sleman District, Yogyakarta Province, Indonesia. Subjects were being explained about the study intervention and were given informed consent as an approval of joining this study. The intervention was given everyday as much as 75g cookies for several weeks period (until delivery). Examination on fetal growth was done every month for each subjects. Birth weight and length were collected after delivery from child health book record.

Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Snakehead fish cookies

Subjects who were given intervention of snakehead fish cookies during the study period

Group Type EXPERIMENTAL

cookies

Intervention Type DIETARY_SUPPLEMENT

Either snakehead fish cookies or standard cookies were given to subjects 75g per day.

Standard cookies

Subjects who were in control group and received standard cookies

Group Type PLACEBO_COMPARATOR

cookies

Intervention Type DIETARY_SUPPLEMENT

Either snakehead fish cookies or standard cookies were given to subjects 75g per day.

Interventions

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cookies

Either snakehead fish cookies or standard cookies were given to subjects 75g per day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. second and third trimester gestational age,
2. lower-class family with income under Sleman District minimum wage in 2019 (\< 1,701,000 Rupiah),
3. pregnant women of under 25 years old, and
4. high school graduate or below

Exclusion Criteria

1. suffering from anemia,
2. experiencing preeclampsia,
3. having multiple gestational, and
4. allergic to fish, eggs, and chocolate.
Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia-MoH

OTHER_GOV

Sponsor Role collaborator

Gadjah Mada University

OTHER

Sponsor Role lead

Responsible Party

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Eugenius Phyowai Ganap

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eugenius P Ganap, PhD

Role: PRINCIPAL_INVESTIGATOR

Gadjah Mada University

Locations

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Public Health Center (Puskesmas) in the area of Sleman District

Sleman, Special Region of Yogyakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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Snakehead fish cookies

Identifier Type: -

Identifier Source: org_study_id

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