NCT00945698

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,920

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.8 years

First QC Date

July 21, 2009

Last Update Submit

May 26, 2015

Conditions

Malnutrition

Keywords

StuntingGrowth failureMalnutritionLipid based nutrient supplementLNSPreventionMalawiSub-Saharan AfricaDietary supplementationEfficacy

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Incidence of serious adverse events during the study period

    12 months after enrollment (age 18 months)

Secondary Outcomes (12)

  • 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)

  • Incidence of stunting, underweight, and wasting

    Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)

  • Prevalence of reduced appetite

    Daily assessment during 12 month supplementation

  • Energy intake from complementary foods

    3 and 9 months after enrollment (age 9 and 15 months)

  • Incidence of laboratory-confirmed malaria infection

    12 months after enrollment (age 18 months)

  • +7 more secondary outcomes

Study Arms (6)

ST-DI (Delayed intervention)

OTHER

* 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

LNS-10gM

EXPERIMENTAL

* 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

LNS-20gM

EXPERIMENTAL

* 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

LNS-20gNoM

EXPERIMENTAL

* 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

LNS-40gM

EXPERIMENTAL

* 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

LNS-40gNoM

EXPERIMENTAL

* 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

Interventions

Lipid-based nutrient supplement, 10gMDIETARY_SUPPLEMENT

* 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

LNS-10gM
Lipid-based nutrient supplement, 20gMDIETARY_SUPPLEMENT

* 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

LNS-20gM
Lipid-based Nutrient Supplement, 20gNoMDIETARY_SUPPLEMENT

* 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

LNS-20gNoM
Lipid-based nutrient supplement, 40gMDIETARY_SUPPLEMENT

* 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

LNS-40gM
Lipid-based Nutrient Supplement, 40gNoMDIETARY_SUPPLEMENT

* 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

LNS-40gNoM
Maize-soy flourDIETARY_SUPPLEMENT

* 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

ST-DI (Delayed intervention)

Eligibility Criteria

Age167 Days - 197 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malawi, College of Medicine

Mangochi, Malawi

Location

Related Publications (13)

  • 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. doi: 10.1093/ajcn/87.4.929.

    PMID: 18400716BACKGROUND

  • 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.

    PMID: 18606932BACKGROUND

  • 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.

    PMID: 19056572BACKGROUND

  • Bendabenda J, Patson N, Hallamaa L, Ashorn U, Dewey KG, Ashorn P, Maleta K. Does anthropometric status at 6 months predict the over-dispersion of malaria infections in children aged 6-18 months? A prospective cohort study. Malar J. 2019 Apr 22;18(1):143. doi: 10.1186/s12936-019-2778-y.

    PMID: 31010435DERIVED

  • Bendabenda J, Patson N, Hallamaa L, Mbotwa J, Mangani C, Phuka J, Prado EL, Cheung YB, Ashorn U, Dewey KG, Ashorn P, Maleta K. The association of malaria morbidity with linear growth, hemoglobin, iron status, and development in young Malawian children: a prospective cohort study. BMC Pediatr. 2018 Dec 28;18(1):396. doi: 10.1186/s12887-018-1378-2.

    PMID: 30593271DERIVED

  • Kumwenda C, Hemsworth J, Phuka J, Ashorn U, Arimond M, Maleta K, Prado EL, Haskell MJ, Dewey KG, Ashorn P. Association between breast milk intake at 9-10 months of age and growth and development among Malawian young children. Matern Child Nutr. 2018 Jul;14(3):e12582. doi: 10.1111/mcn.12582. Epub 2018 Jan 19.

    PMID: 29349922DERIVED

  • Adams KP, Ayifah E, Phiri TE, Mridha MK, Adu-Afarwuah S, Arimond M, Arnold CD, Cummins J, Hussain S, Kumwenda C, Matias SL, Ashorn U, Lartey A, Maleta KM, Vosti SA, Dewey KG. Maternal and Child Supplementation with Lipid-Based Nutrient Supplements, but Not Child Supplementation Alone, Decreases Self-Reported Household Food Insecurity in Some Settings. J Nutr. 2017 Dec;147(12):2309-2318. doi: 10.3945/jn.117.257386. Epub 2017 Oct 4.

    PMID: 28978680DERIVED

  • Prado EL, Abbeddou S, Adu-Afarwuah S, Arimond M, Ashorn P, Ashorn U, Brown KH, Hess SY, Lartey A, Maleta K, Ocansey E, Ouedraogo JB, Phuka J, Some JW, Vosti SA, Yakes Jimenez E, Dewey KG. Linear Growth and Child Development in Burkina Faso, Ghana, and Malawi. Pediatrics. 2016 Aug;138(2):e20154698. doi: 10.1542/peds.2015-4698.

    PMID: 27474016DERIVED

  • Bendabenda J, Alho L, Ashorn U, Cheung YB, Dewey KG, Vosti SA, Phuka J, Maleta K, Ashorn P. The effect of providing lipid-based nutrient supplements on morbidity in rural Malawian infants and young children: a randomized controlled trial. Public Health Nutr. 2016 Jul;19(10):1893-903. doi: 10.1017/S1368980016000331. Epub 2016 Mar 9.

    PMID: 26956611DERIVED

  • Hemsworth J, Kumwenda C, Arimond M, Maleta K, Phuka J, Rehman AM, Vosti SA, Ashorn U, Filteau S, Dewey KG, Ashorn P, Ferguson EL. Lipid-Based Nutrient Supplements Increase Energy and Macronutrient Intakes from Complementary Food among Malawian Infants. J Nutr. 2016 Feb;146(2):326-34. doi: 10.3945/jn.115.215327. Epub 2016 Jan 6.

    PMID: 26740684DERIVED

  • Maleta KM, Phuka J, Alho L, Cheung YB, Dewey KG, Ashorn U, Phiri N, Phiri TE, Vosti SA, Zeilani M, Kumwenda C, Bendabenda J, Pulakka A, Ashorn P. Provision of 10-40 g/d Lipid-Based Nutrient Supplements from 6 to 18 Months of Age Does Not Prevent Linear Growth Faltering in Malawi. J Nutr. 2015 Aug;145(8):1909-15. doi: 10.3945/jn.114.208181. Epub 2015 Jun 10.

    PMID: 26063066DERIVED

  • Ashorn U, Alho L, Arimond M, Dewey KG, Maleta K, Phiri N, Phuka J, Vosti SA, Zeilani M, Ashorn P. Malawian Mothers Consider Lipid-Based Nutrient Supplements Acceptable for Children throughout a 1-Year Intervention, but Deviation from User Recommendations Is Common. J Nutr. 2015 Jul;145(7):1588-95. doi: 10.3945/jn.114.209593. Epub 2015 May 20.

    PMID: 25995276DERIVED

  • Kumwenda C, Dewey KG, Hemsworth J, Ashorn P, Maleta K, Haskell MJ. Lipid-based nutrient supplements do not decrease breast milk intake of Malawian infants. Am J Clin Nutr. 2014 Mar;99(3):617-23. doi: 10.3945/ajcn.113.076588. Epub 2013 Dec 24.

    PMID: 24368436DERIVED

Related Links

MeSH Terms

Conditions

MalnutritionGrowth DisordersFailure to Thrive

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Per Ashorn, MD, PhD

    University of Tampere Medical School

    PRINCIPAL INVESTIGATOR

  • Kenneth Maleta, MBBS, PhD

    Kamuzu University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of International Health

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 24, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

MA(1)