Trial to Test the Growth-Promoting Effect of Fortified Spreads When Used as Complementary Food for Infants

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

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-01-31

Brief Summary

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This study tests the hypothesis that infants receiving fortified spread as a complementary food for one year grow better and do not become malnourished as often as infants who are provided with maize-soy flour for complementary porridge.

Detailed Description

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Childhood undernutrition is very common in rural Malawi, like in many other countries in Sub-Saharan Africa. Usually, undernutrition develops between 6 and 24 months of age. By two years of age, 30-50% of all children in rural Malawi are undernourished, predisposing them to subsequent morbidity, developmental delay and mortality. Urgent interventions are needed but the magnitude of the problem precludes a hospital-based management strategy. Therefore, emphasis must be on prevention and early home-based rehabilitation of children with mild-to-moderate malnutrition. However, the options for community based approaches are not as developed as those for institutional management of undernutrition.

The present study tests a recently developed nutrient -dense spread, ready-to use- therapeutic food (RUTF), which offers a potential solution to home based nutrition rehabilitation. The concept has previously been shown to work not only in therapeutic feeding of undernourished children in nutrition rehabilitation units in Malawi but also home based supplementation of undernourished children in Mangochi District, southern Malawi. In the present study the investigators will test the efficacy in growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age.

The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 180 6-month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 months. Children in group-one (control group) will receive 75g of maize/soy flour daily. Children in group-two will receive 25g RUTF daily and children in group-three will receive 50g RUTF daily for a period of 12 months. The food supplements will be delivered to the participant's home at weekly intervals.

All children will undergo medical and anthropometric examinations at 4-monthly intervals and disease symptoms monitoring every week. Dietary intake assessments will be conducted at 12 and 15 months of age. A random sample of 36 children will undergo breast milk intake assessments before the start of food supplementation and during food supplementation. A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations and test human immunodeficiency virus \[HIV\] (at 6 and 18 months).

The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups. Secondary outcomes include length gain, incidence of moderate underweight, stunting and wasting, cognitive and motor development at the end of trial and changes in blood haemoglobin and serum ferritin concentration. The study will also produce descriptive data on morbidity and intake of breast milk and other foods during the intervention.

Conditions

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Malnutrition

Keywords

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Infant Sub-Saharan Africa Complementary feeding Malnutrition Growth Fortified spread Haemoglobin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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fortified spread (RUTF)

Intervention Type DIETARY_SUPPLEMENT

maize and soy flour

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent from at least one guardian
* Ages 5.50 months to 6.49 months
* Availability during the period of the study
* Permanent resident of the area

Exclusion Criteria

* WHZ \< -2.0 z-scores or presence of oedema
* History of peanut allergy
* Severe illness warranting hospital referral
* Concurrent participation of the child in another clinical trial with intervention to the child

Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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University of Tampere Medical School, Finland

Principal Investigators

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Per Ashorn, MD, PhD

Role: STUDY_DIRECTOR

University of Tampere, Medical School

Kenneth Maleta, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Kamuzu University of Health Sciences

Locations

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College of Medicine, University of Malawi

Mangochi, Mangochi District, Malawi

Site Status

Countries

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Malawi

References

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Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour. Am J Clin Nutr. 2009 Jan;89(1):382-90. doi: 10.3945/ajcn.2008.26483. Epub 2008 Dec 3.

Reference Type DERIVED

PMID: 19056572 (View on PubMed)

Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians. Arch Pediatr Adolesc Med. 2008 Jul;162(7):619-26. doi: 10.1001/archpedi.162.7.619.