Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants (LCNI-5)

May 20, 2014 updated by: Per Ashorn, Tampere University

A Single-centre, Randomised, Single-blind, Parallel Group Clinical Trial in Rural Malawi, Testing the Growth Promoting Effect of Long-term Complementary Feeding of Infants With a High-energy, Micronutrient Fortified Spread

This study tests the hypothesis that infants receiving milk-powder containing fortified spread (lipid-based nutrient supplement) as a complementary food for one year have lower incidence of severe stunting (poor length gain) than infants who are provided with no extra food supplements or maize-soy flour for complementary porridge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Poor growth and severe childhood stunting is very common in rural Malawi and elsewhere in Sub-Sahara Africa. To date, few interventions have proven successful in promoting linear growth in early childhood. Our preliminary results from Malawi suggest that a year-long daily complementary feeding of infants with a high-energy, micronutrient-fortified spread (FS) may markedly reduce the incidence of severe stunting before the age of 18 months. In the present study the investigators will more carefully analyze the efficacy in linear 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. Six-month old healthy infants are identified through community surveys in the study area. 840 infants meeting set criteria are randomized into receiving the following intervention between 6 and 18 months of age: 1) standard treatment ie no extra food supplements (but dietary supplementation between 18 and 30 months of age) (ST-DI, control group), 2), "standard" fortified spread with milk-powder as the protein source (FSm), 3) modified fortified spread with soy-powder as the protein source (FSs), or 4) fortified maize-soy flour (likuni phala, LP). The families receive the food supplements at 2-weekly intervals and the participants undergo an anthropometric and developmental evaluation and laboratory analyses at 12-week intervals. Outcome analyses are done at 18 and at 36 months of age.

The impact of the dietary interventions will be primarily assessed by comparing the incidence of severe stunting in the four study groups. Secondary outcomes include a number of anthropometric variables, morbidity, developmental milestones, and laboratory parameters. The study will also produce descriptive data on possible mechanisms for growth failure among the trial subjects.

Study Type

Interventional

Enrollment (Anticipated)

840

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Mangochi, Malawi
        • College of Medicine, University of Malawi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent from at least one guardian
  • Age 5.50 months to 6.49 months
  • Availability during the period of the study.
  • Permanent resident of Lungwena Health Centre or Malindi Hospital catchment area

Exclusion Criteria:

  • Existing or imminent severe stunting (HAZ < -2.8)
  • Weight for length (WFH) < 80% of the reference median or presence of oedema
  • Severe illness warranting hospital referral.
  • History of allergy towards peanut
  • History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
  • Concurrent participation in any other clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: ST-DI
Standard treatment - delayed intervention. Counselling on complementary feeding + Vitamin A (200,000 IU) every 6 months until 36 months + 1 kg maize / soy flour 2-weekly (71 g / day) between 18 and 30 months of age.
Experimental: FSm
Fortified Spread (milk). Counseling + Vitamin A as for ST-DI + 750 g of fortified spread (FSm) 2-weekly (54 g / day) between 6 and 18 months of age.
Dietary supplement: Milk-containing fortified spread
Counseling + Vitamin A as for ST-DI + 750 g of fortified spread (FSm) 2-weekly (54 g / day) between 6 and 18 months of age.
Experimental: FSs
Counselling + Vitamin A as for ST-DI + 750 g of modified fortified spread (FSs) 2-weekly (54 g / day) between 6 and 18 months of age.
Dietary supplement: Soy-containing fortified spread
Counseling + Vitamin A as for ST-DI + 750 g of modified fortified spread (FSs) 2-weekly (54 g / day) between 6 and 18 months of age.
Experimental: LP
Likuni Phala. Counseling + Vitamin A as for ST-DI + 1 kg fortified maize / soy flour 2-weekly (71 g / day) between 6 and 18 months of age.
Dietary supplement: Maize-soy flour
Counseling + Vitamin A as for ST_DI + 1 kg fortified maize / soy flour 2-weekly (71 g / day) between 6 and 18 months of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of severe stunting (Length-for-age Z score < -3)
Time Frame: 1 year after enrolment
1 year after enrolment
Incidence of serious and non-serious adverse events
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of moderate or severe stunting (Length-for-age Z-score < -2)
Time Frame: 1 year
1 year
Length gain (cm)
Time Frame: 1 year
1 year
Weight gain (g)
Time Frame: 1 year
1 year
Change in anthropometric indices (Weight-for-age Z-score, Weight-for-length Z-score, Length-for-age Z-score), mid-upper arm circumference and head circumference
Time Frame: 1 year
1 year
Incidence of moderate or severe underweight or wasting (Weight-for-age Z-score or Weight-for-length Z-score <-2 / -3 SD units)
Time Frame: 1 year
1 year
Blood haemoglobin, serum ferritin, vitamin A, and zinc concentration
Time Frame: 18 months of age
18 months of age
Motor, social, and language development (timing of acquisition of defined skills)
Time Frame: 1 year
1 year
Incidence of febrile illnesses and laboratory diagnosed malaria
Time Frame: 1 year
1 year
Morbidity for respiratory infections, diarrhea, and other illnesses
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University

Collaborators

Kamuzu University of Health Sciences
Academy of Finland
Foundation for Paediatric Research, Finland
Medical Research Fund of the Tampere University Hospital, Finland

Investigators

  • Principal Investigator: Kenneth Maleta, MBBS, PhD, Kamuzu University of Health Sciences
  • Study Director: Per Ashorn, MD, PhD, University of Tampere Medical School, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

August 31, 2007

First Submitted That Met QC Criteria

August 31, 2007

First Posted (Estimate)

September 3, 2007

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTS-2007-02-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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