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

Primary Purpose

Malnutrition, Stunting, Developmental Delay

Status
Completed
Phase
Phase 3
Locations
Malawi
Study Type
Interventional
Intervention
Milk-containing fortified spread
Soy-containing fortified spread
Maize-soy flour
Sponsored by
Tampere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Infant, Sub-Saharan Africa, Complementary feeding, Fortified spread, Lipid-based nutrient supplement, Malnutrition, Stunting, Growth, Morbidity, Development, Haemoglobin

Eligibility Criteria

6 Months - 6 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • College of Medicine, University of Malawi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

ST-DI

FSm

FSs

LP

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Incidence of severe stunting (Length-for-age Z score < -3)
Incidence of serious and non-serious adverse events

Secondary Outcome Measures

Incidence of moderate or severe stunting (Length-for-age Z-score < -2)
Length gain (cm)
Weight gain (g)
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
Incidence of moderate or severe underweight or wasting (Weight-for-age Z-score or Weight-for-length Z-score <-2 / -3 SD units)
Blood haemoglobin, serum ferritin, vitamin A, and zinc concentration
Motor, social, and language development (timing of acquisition of defined skills)
Incidence of febrile illnesses and laboratory diagnosed malaria
Morbidity for respiratory infections, diarrhea, and other illnesses

Full Information

First Posted
August 31, 2007
Last Updated
May 20, 2014
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
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1. Study Identification

Unique Protocol Identification Number
NCT00524446
Brief Title
Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants
Acronym
LCNI-5
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Stunting, Developmental Delay
Keywords
Infant, Sub-Saharan Africa, Complementary feeding, Fortified spread, Lipid-based nutrient supplement, Malnutrition, Stunting, Growth, Morbidity, Development, Haemoglobin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ST-DI
Arm Type
No Intervention
Arm Description
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.
Arm Title
FSm
Arm Type
Experimental
Arm Description
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.
Arm Title
FSs
Arm Type
Experimental
Arm Description
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.
Arm Title
LP
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Milk-containing fortified spread
Intervention Description
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 Type
Dietary Supplement
Intervention Name(s)
Soy-containing fortified spread
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maize-soy flour
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of severe stunting (Length-for-age Z score < -3)
Time Frame
1 year after enrolment
Title
Incidence of serious and non-serious adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of moderate or severe stunting (Length-for-age Z-score < -2)
Time Frame
1 year
Title
Length gain (cm)
Time Frame
1 year
Title
Weight gain (g)
Time Frame
1 year
Title
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
Title
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
Title
Blood haemoglobin, serum ferritin, vitamin A, and zinc concentration
Time Frame
18 months of age
Title
Motor, social, and language development (timing of acquisition of defined skills)
Time Frame
1 year
Title
Incidence of febrile illnesses and laboratory diagnosed malaria
Time Frame
1 year
Title
Morbidity for respiratory infections, diarrhea, and other illnesses
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Ashorn, MD, PhD
Organizational Affiliation
University of Tampere Medical School, Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kenneth Maleta, MBBS, PhD
Organizational Affiliation
Kamuzu University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Medicine, University of Malawi
City
Mangochi
Country
Malawi

12. IPD Sharing Statement

Citations:
PubMed Identifier
27798342
Citation
Xu G, Davis JC, Goonatilleke E, Smilowitz JT, German JB, Lebrilla CB. Absolute Quantitation of Human Milk Oligosaccharides Reveals Phenotypic Variations during Lactation. J Nutr. 2017 Jan;147(1):117-124. doi: 10.3945/jn.116.238279. Epub 2016 Oct 19.
Results Reference
derived
PubMed Identifier
27403608
Citation
Aakko J, Grzeskowiak L, Asukas T, Paivansade E, Lehto KM, Fan YM, Mangani C, Maleta K, Ashorn P, Salminen S. Lipid-based Nutrient Supplements Do Not Affect Gut Bifidobacterium Microbiota in Malawian Infants: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):610-615. doi: 10.1097/MPG.0000000000001333.
Results Reference
derived
PubMed Identifier
25332483
Citation
Mangani C, Ashorn P, Maleta K, Phuka J, Thakwalakwa C, Dewey K, Manary M, Puumalainen T, Cheung YB. Lipid-based nutrient supplements do not affect the risk of malaria or respiratory morbidity in 6- to 18-month-old Malawian children in a randomized controlled trial. J Nutr. 2014 Nov;144(11):1835-42. doi: 10.3945/jn.114.196139. Epub 2014 Sep 17.
Results Reference
derived
PubMed Identifier
22228076
Citation
Grzeskowiak L, 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.
Results Reference
derived
Links:
URL
http://www.medcol.mw/
Description
College of Medicine homepage

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

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