Prevention of Linear Growth Failure in Infants and Young Children With Lipid-based Nutrient Supplements (iLiNS-DOSE) - Full Text View

Purpose

The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to infants and their guardians in Malawi and Ghana. In the present trial, the investigator aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the investigators will test a hypothesis that LNS that does not contain milk promotes growth as well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month old infants in rural Malawi.

Condition	Intervention	Phase
Malnutrition	Dietary Supplement: Lipid-based nutrient supplement, 10gM Dietary Supplement: Lipid-based nutrient supplement, 20gM Dietary Supplement: Lipid-based Nutrient Supplement, 20gNoM Dietary Supplement: Lipid-based nutrient supplement, 40gM Dietary Supplement: Lipid-based Nutrient Supplement, 40gNoM Dietary Supplement: Maize-soy flour	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Two-centre, Randomised, Single-blind, Parallel Group Controlled Trial, Testing the Growth Promoting Effect of Long-term Complementary Feeding of Infants With Different Doses and Formulations of Lipid-based Nutrient Supplements (LNS)

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Malnutrition Vitamin A

Drug Information available for: Retinol Vitamin A palmitate Vitamin A

U.S. FDA Resources

Further study details as provided by University of Tampere:

Primary Outcome Measures:

Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age [ Time Frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months) ] [ Designated as safety issue: No ]
Incidence of serious adverse events during the study period [ Time Frame: 12 months after enrollment (age 18 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in weight-for-age (WAZ) and weight-for-length (WLZ) Z-scores [ Time Frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months) ] [ Designated as safety issue: No ]
Incidence of stunting, underweight, and wasting [ Time Frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months) ] [ Designated as safety issue: No ]
Prevalence of reduced appetite [ Time Frame: Daily assessment during 12 month supplementation ] [ Designated as safety issue: No ]
Energy intake from complementary foods [ Time Frame: 3 and 9 months after enrollment (age 9 and 15 months) ] [ Designated as safety issue: No ]
Incidence of laboratory-confirmed malaria infection [ Time Frame: 12 months after enrollment (age 18 months) ] [ Designated as safety issue: No ]
Incidence of caregiver-reported morbidity [ Time Frame: Daily assessment during 12 month supplementation ] [ Designated as safety issue: No ]
Immune function (measured by humoral immunity towards measles vaccination) [ Time Frame: 12 months after enrollment (age 18 months) ] [ Designated as safety issue: No ]
Change in hemoglobin and micronutrient status (iron status, measured by zinc protoporphyrin (ZPP); plasma zinc; plasma vitamin A; B-vitamins and related metabolites; urine iodine [ Time Frame: 12 months after enrollment (age 18 months) ] [ Designated as safety issue: No ]
Proportion with anaemia at 18 months of age [ Time Frame: 12 months after enrollment (age 18 months) ] [ Designated as safety issue: No ]
Change in erythrocyte essential fatty acid (EFA) concentration (measured from a subsample of 400 participants) [ Time Frame: 12 months after enrollment (age 18 months) ] [ Designated as safety issue: No ]
Neuro-behavioral development (timing of acquisition of the certain skills and more comprehensive analysis at the age of 18 months) [ Time Frame: Limited assessment every 4 weeks during the 12 months supplementation, more comprehensive at age 18 months ] [ Designated as safety issue: No ]
Incidence of all adverse events during the study period [ Time Frame: 12 months after enrollment (age 18 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1920
Study Start Date:	November 2009
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ST-DI (Delayed intervention) 1 kg fortified maize / soy flour (Likuni phala, LP) 2-weekly (71 g / day) between 18 and 30 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring	Dietary Supplement: Maize-soy flour No food supplement during the primary trial period (6 to 18 months of age) 1 kg fortified maize / soy flour (Likuni phala, LP) 2-weekly (71 g / day) between 18 and 30 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Experimental: LNS-10gM 140 g of milk-containing LNS (LNS-10gM) 2-weekly (10 g / day) between 6 and 18 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring	Dietary Supplement: Lipid-based nutrient supplement, 10gM 140 g of milk-containing LNS (LNS-10gM) 2-weekly (10 g / day) between 6 and 18 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Experimental: LNS-20gM 280 g of milk-containing LNS (LNS-20gM) 2-weekly (20 g / day) between 6 and 18 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring	Dietary Supplement: Lipid-based nutrient supplement, 20gM 280 g of milk-containing LNS (LNS-20gM) 2-weekly (20 g / day) between 6 and 18 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Experimental: LNS-20gNoM 280 g of milk-free LNS (LNS-20gNoM) 2-weekly (20 g / day) between 6 and 18 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring	Dietary Supplement: Lipid-based Nutrient Supplement, 20gNoM 280 g of milk-free LNS (LNS-20gNoM) 2-weekly (20 g / day) between 6 and 18 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Experimental: LNS-40gM 560 g of milk-containing LNS (LNS-40gM) 2-weekly (40 g / day) between 6 and 18 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring	Dietary Supplement: Lipid-based nutrient supplement, 40gM 560 g of milk-containing LNS (LNS-40gM) 2-weekly (40 g / day) between 6 and 18 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Experimental: LNS-40gNoM 560 g of milk-free LNS (LNS-40gNoM) 2-weekly (40 g / day) between 6 and 18 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring	Dietary Supplement: Lipid-based Nutrient Supplement, 40gNoM 560 g of milk-free LNS (LNS-40gNoM) 2-weekly (40 g / day) between 6 and 18 months of age Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

Detailed Description:

Six-month old healthy infants are identified through community surveys in the study area. 1920 infants meeting set criteria are randomised into receiving the following intervention between 6 and 18 months of age: 1) standard treatment from 6-18 months (i.e.no supplements, with delayed intervention between 18-30 months of age (ST-DI), 2) 10 g / day milk-containing LNS (LNS-10gM), 3) 20 g / day milk-containing LNS (LNS-20gM), 4) 20 g / day milk-free LNS (LNS-20gNoM), 5) 40 g / day milk-containing LNS, (LNS-40gM) 6) 40 g / day milk-free LNS (LNS-40gNoM). The families receive the food supplements at 2-weekly intervals and the participants undergo a morbidity evaluation weekly, a limited development assessment at 4-weekly intervals and anthropometric evaluation at 26-week intervals and laboratory analyses at enrollment and at 18 months. Growth outcome analyses are done at 18 and at 42 months of age.

Eligibility

Ages Eligible for Study:	167 Days to 197 Days
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 Mangochi District Hospital or Namwera Health Centre catchment area

Exclusion Criteria:

Weight for length Z score (WLZ) < -2.0
Presence of oedema
Severe anaemia (Hb<50 g / l)
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945698

Locations

Malawi
University of Malawi, College of Medicine
Mangochi, Malawi

Sponsors and Collaborators

University of Tampere

University of Malawi College of Medicine

University of California, Davis

Bill and Melinda Gates Foundation

Investigators

Principal Investigator:	Per Ashorn, MD, PhD	University of Tampere Medical School
Principal Investigator:	Kenneth Maleta, MBBS, PhD	University of Malawi College of Medicine

More Information

Additional Information:

College of Medicine homepage This link exits the ClinicalTrials.gov site

Home page for University of Tampere Medical School, Department of International Health This link exits the ClinicalTrials.gov site

Publications:

Adu-Afarwuah S, Lartey A, Brown KH, Zlotkin S, Briend A, Dewey KG. Home fortification of complementary foods with micronutrient supplements is well accepted and has positive effects on infant iron status in Ghana. Am J Clin Nutr. 2008 Apr;87(4):929-38.

Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians. Arch Pediatr Adolesc Med. 2008 Jul;162(7):619-26.

Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour. Am J Clin Nutr. 2009 Jan;89(1):382-90. Epub 2008 Dec 3.

Responsible Party:	Per Ashorn, Professor of International Health, University of Tampere
ClinicalTrials.gov Identifier:	NCT00945698 History of Changes
Other Study ID Numbers:	iLiNS-DOSE
Study First Received:	July 21, 2009
Last Updated:	June 17, 2012
Health Authority:	Malawi: College of Medicine Research and Ethics Committee

Keywords provided by University of Tampere:

Stunting
Growth failure
Malnutrition
Lipid based nutrient supplement
LNS

Prevention
Malawi
Sub-Saharan Africa
Dietary supplementation
Efficacy

Additional relevant MeSH terms:

Failure to Thrive
Malnutrition
Growth Disorders
Pathologic Processes
Nutrition Disorders

ClinicalTrials.gov processed this record on May 22, 2013