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

Malnutrition Clinical Trial

— iLiNS-DOSE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945698
• Other study ID #: iLiNS-DOSE
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2009
• Last updated: May 26, 2015
• Start date: November 2009
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1920
• Est. completion date: August 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 167 Days to 197 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malnutrition

Intervention

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
• 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
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
Malawi	University of Malawi, College of Medicine	Mangochi

Sponsors (4)

Lead Sponsor	Collaborator
University of Tampere	Bill and Melinda Gates Foundation, University of California, Davis, University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

References & Publications (3)

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. — View Citation

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. doi: 10.1001/archpedi.162.7.619. Erratum in: Arch Pediatr Adolesc Med. 2008 Oct;162(10):942. — View Citation

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. doi: 10.3945/ajcn.2008.26483. Epub 2008 Dec 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age		Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)	No
Primary	Incidence of serious adverse events during the study period		12 months after enrollment (age 18 months)	Yes
Secondary	Change in weight-for-age (WAZ) and weight-for-length (WLZ) Z-scores		Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)	No
Secondary	Incidence of stunting, underweight, and wasting		Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)	No
Secondary	Prevalence of reduced appetite		Daily assessment during 12 month supplementation	No
Secondary	Energy intake from complementary foods		3 and 9 months after enrollment (age 9 and 15 months)	No
Secondary	Incidence of laboratory-confirmed malaria infection		12 months after enrollment (age 18 months)	No
Secondary	Incidence of caregiver-reported morbidity		Daily assessment during 12 month supplementation	No
Secondary	Immune function (measured by humoral immunity towards measles vaccination)		12 months after enrollment (age 18 months)	No
Secondary	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		12 months after enrollment (age 18 months)	No
Secondary	Proportion with anaemia at 18 months of age		12 months after enrollment (age 18 months)	No
Secondary	Change in erythrocyte essential fatty acid (EFA) concentration (measured from a subsample of 400 participants)		12 months after enrollment (age 18 months)	No
Secondary	Neuro-behavioral development (timing of acquisition of the certain skills and more comprehensive analysis at the age of 18 months)		Limited assessment every 4 weeks during the 12 months supplementation, more comprehensive at age 18 months	No
Secondary	Incidence of all adverse events during the study period		12 months after enrollment (age 18 months)	Yes

External Links

•   College of Medicine homepage
•   Home page for University of Tampere Medical School, Department of International Health