Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh

NCT ID: NCT01553877

Last Updated: 2013-01-03

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

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-05-31

Brief Summary

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The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access to preventive as well as curative health services, and good prenatal care. The proposed research is on the possible options for providing a nutritious diet, realizing the constraints of poverty and food insecurity faced by care givers whose children are at risk of developing or confirmed to be suffering from moderate malnutrition. Even when people are not typically food insecure but consume a relatively monotonous diet with few good-quality foods, they also have to have options for dietary improvement, and especially the possibility of ready-to-use complementary food supplements (RUCFS) for young children. This proposed research on development of RUCFS will pave the way for programmatic considerations for expansion of the use of new complementary food supplements for preventing malnutrition among young children in Bangladesh.

Detailed Description

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Conditions

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Moderately Malnourished Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Pushti Packet

Group Type ACTIVE_COMPARATOR

Pushti packet

Intervention Type DIETARY_SUPPLEMENT

A food composed of roasted rice, roasted lentil, molasses and soybean oil

Rice based Ready to Use Complementary Food Supplements

Group Type EXPERIMENTAL

Rice based Ready to Use Complementary Food Supplements

Intervention Type DIETARY_SUPPLEMENT

A rice based diet.

Chick-pea based Ready to Use Complementary Food Supplements

Group Type ACTIVE_COMPARATOR

Chick-pea based Ready to Use Complementary Food Supplements

Intervention Type DIETARY_SUPPLEMENT

A chick-pea based diet.

Interventions

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Pushti packet

A food composed of roasted rice, roasted lentil, molasses and soybean oil

Intervention Type DIETARY_SUPPLEMENT

Rice based Ready to Use Complementary Food Supplements

A rice based diet.

Intervention Type DIETARY_SUPPLEMENT

Chick-pea based Ready to Use Complementary Food Supplements

A chick-pea based diet.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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A food composed of roasted rice, roasted lentil, molasses and soybean oil

Eligibility Criteria

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Inclusion Criteria

* 6 to 18 months; either sex, having no acute illness, and be on at least one semi-solid or solid food in a day.

Exclusion Criteria

* loss of appetite,
* oral lesion,
* congenital anomaly/acquired disorder affecting growth,
* severe acute malnutrition (SAM) defined by:

* MUAC \< 115 mm or
* WL \< -3 Z score or
* bipedal edema,
* persistent diarrhea,
* tuberculosis,
* any other chronic illness.
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ICDDR,B

Dhaka, Dhaka Division, Bangladesh

Site Status

Countries

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Bangladesh

References

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Ahmed T, Choudhury N, Hossain MI, Tangsuphoom N, Islam MM, de Pee S, Steiger G, Fuli R, Sarker SA, Parveen M, West KP Jr, Christian P. Development and acceptability testing of ready-to-use supplementary food made from locally available food ingredients in Bangladesh. BMC Pediatr. 2014 Jun 27;14:164. doi: 10.1186/1471-2431-14-164.

Reference Type DERIVED
PMID: 24972632 (View on PubMed)

Other Identifiers

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PR-10066

Identifier Type: -

Identifier Source: org_study_id

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