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

This study has been completed.
Sponsor:
Collaborators:
University of Malawi College of Medicine
Academy of Finland
Foundation for Paediatric Research, Finland
Medical Research Fund of the Tampere University Hospital, Finland
Information provided by (Responsible Party):
Per Ashorn, University of Tampere
ClinicalTrials.gov Identifier:
NCT00524446
First received: August 31, 2007
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Malnutrition
Stunting
Developmental Delay
Dietary Supplement: Milk-containing fortified spread
Dietary Supplement: Soy-containing fortified spread
Dietary Supplement: Maize-soy flour
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • Incidence of severe stunting (Length-for-age Z score < -3) [ Time Frame: 1 year after enrolment ] [ Designated as safety issue: No ]
  • Incidence of serious and non-serious adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of moderate or severe stunting (Length-for-age Z-score < -2) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Length gain (cm) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Weight gain (g) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Blood haemoglobin, serum ferritin, vitamin A, and zinc concentration [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
  • Motor, social, and language development (timing of acquisition of defined skills) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Incidence of febrile illnesses and laboratory diagnosed malaria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Morbidity for respiratory infections, diarrhea, and other illnesses [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 840
Study Start Date: January 2008
Study Completion Date: January 2014
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   6 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00524446

Locations
Malawi
College of Medicine, University of Malawi
Mangochi, Malawi
Sponsors and Collaborators
University of Tampere
University of Malawi College of Medicine
Academy of Finland
Foundation for Paediatric Research, Finland
Medical Research Fund of the Tampere University Hospital, Finland
Investigators
Study Director: Per Ashorn, MD, PhD University of Tampere Medical School, Finland
Principal Investigator: Kenneth Maleta, MBBS, PhD College of Medicine, University of Malawi
  More Information

Additional Information:
No publications provided by University of Tampere

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Per Ashorn, Professor of International Health, University of Tampere
ClinicalTrials.gov Identifier: NCT00524446     History of Changes
Other Study ID Numbers: LTS-2007-02-19
Study First Received: August 31, 2007
Last Updated: May 20, 2014
Health Authority: Malawi: College of Medicine Research and Ethics Committee

Keywords provided by University of Tampere:
Infant
Sub-Saharan Africa
Complementary feeding
Fortified spread
Lipid-based nutrient supplement
Malnutrition
Stunting
Growth
Morbidity
Development
Haemoglobin

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 18, 2014