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Trial record 6 of 114 for:    test | ( Map: Malawi )

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

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ClinicalTrials.gov Identifier: NCT00524446
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : May 21, 2014
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, Tampere University

Tracking Information
First Submitted Date  ICMJE August 31, 2007
First Posted Date  ICMJE September 3, 2007
Last Update Posted Date May 21, 2014
Study Start Date  ICMJE January 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00524446 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2007)
  • Incidence of moderate or severe stunting (Length-for-age Z-score < -2) [ Time Frame: 1 year ]
  • Length gain (cm) [ Time Frame: 1 year ]
  • Weight gain (g) [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Malnutrition
  • Stunting
  • Developmental Delay
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 31, 2007)
840
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00524446
Other Study ID Numbers  ICMJE LTS-2007-02-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Per Ashorn, Tampere University
Study Sponsor  ICMJE Tampere University
Collaborators  ICMJE
  • University of Malawi College of Medicine
  • Academy of Finland
  • Foundation for Paediatric Research, Finland
  • Medical Research Fund of the Tampere University Hospital, Finland
Investigators  ICMJE
Study Director: Per Ashorn, MD, PhD University of Tampere Medical School, Finland
Principal Investigator: Kenneth Maleta, MBBS, PhD University of Malawi College of Medicine
PRS Account Tampere University
Verification Date May 2014

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