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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

August 31, 2007
May 20, 2014
January 2008
June 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Incidence of severe stunting (Length-for-age Z score < -3) [ Time Frame: 1 year after enrolment ]
  • Incidence of serious and non-serious adverse events [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00524446 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incidence of moderate or severe stunting (HAZ < -2) [ Time Frame: 1 year ]
  • Length gain (cm) [ Time Frame: 1 year ]
  • Weight gain (g) [ Time Frame: 1 year ]
  • Change in anthropometric indices (WAZ, WHZ, HAZ), mid-upper arm circumference and head circumference [ Time Frame: 1 year ]
  • Incidence of moderate or severe underweight or wasting (WAZ or WHZ <-2 / -3 SD units) [ Time Frame: 1 year ]
  • Blood haemoglobin, serum ferritin, vitamin A, and zinc concentration [ Time Frame: 18 months of age ]
  • Motor, social, and language development (timing of acquisition of defined skills) [ Time Frame: 1 year ]
  • Incidence of febrile illnesses and laboratory diagnosed malaria [ Time Frame: 1 year ]
  • Morbidity for respiratory infections, diarrhea, and other illnesses [ Time Frame: 1 year ]
Not Provided
Not Provided
 
Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Malnutrition
  • Stunting
  • Developmental Delay
  • 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.
  • 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.
  • 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.
  • 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.
    Intervention: Dietary Supplement: Milk-containing fortified spread
  • 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.
    Intervention: Dietary Supplement: Soy-containing fortified spread
  • 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.
    Intervention: Dietary Supplement: Maize-soy flour
Grześkowiak Ł, Collado MC, Mangani C, Maleta K, Laitinen K, Ashorn P, Isolauri E, Salminen S. Distinct gut microbiota in southeastern African and northern European infants. J Pediatr Gastroenterol Nutr. 2012 Jun;54(6):812-6. doi: 10.1097/MPG.0b013e318249039c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
840
January 2014
June 2011   (final data collection date for primary outcome measure)

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
Both
6 Months to 6 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT00524446
LTS-2007-02-19
Yes
Per Ashorn, University of Tampere
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
Study Director: Per Ashorn, MD, PhD University of Tampere Medical School, Finland
Principal Investigator: Kenneth Maleta, MBBS, PhD College of Medicine, University of Malawi
University of Tampere
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP