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

Conditions

Malnutrition

Keywords

Stunting, Growth failure, Malnutrition, Lipid based nutrient supplement, LNS, Prevention, Malawi, Sub-Saharan Africa, Dietary supplementation, Efficacy

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.

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.

Bendabenda J, Patson N, Hallamaa L, Ashorn U, Dewey KG, Ashorn P, Maleta K.

2019-04-222 citations

10.1186/s12936-019-2778-y

The association of malaria morbidity with linear growth, hemoglobin, iron status, and development in young Malawian children: a prospective cohort study.

Bendabenda J, Patson N, Hallamaa L, Mbotwa J, Mangani C, Phuka J, Prado EL, Cheung YB, Ashorn U, Dewey KG, Ashorn P, Maleta K.

2018-12-289 citations

10.1186/s12887-018-1378-2

Maternal and Child Supplementation with Lipid-Based Nutrient Supplements, but Not Child Supplementation Alone, Decreases Self-Reported Household Food Insecurity in Some Settings.

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.

2017-10-049 citations

10.3945/jn.117.257386

Provision of Lipid-Based Nutrient Supplements from Age 6 to 18 Months Does Not Affect Infant Development Scores in a Randomized Trial in Malawi.

Prado EL, Phuka J, Maleta K, Ashorn P, Ashorn U, Vosti SA, Dewey KG.

2016-10-0120 citations

10.1007/s10995-016-2061-6

Lipid-Based Nutrient Supplements Increase Energy and Macronutrient Intakes from Complementary Food among Malawian Infants.

Hemsworth J, Kumwenda C, Arimond M, Maleta K, Phuka J, Rehman AM, Vosti SA, Ashorn U, Filteau S, Dewey KG, Ashorn P, Ferguson EL.

2016-01-0621 citations

10.3945/jn.115.215327

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.

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.

2015-06-1072 citations

10.3945/jn.114.208181

Malawian Mothers Consider Lipid-Based Nutrient Supplements Acceptable for Children throughout a 1-Year Intervention, but Deviation from User Recommendations Is Common.

Ashorn U, Alho L, Arimond M, Dewey KG, Maleta K, Phiri N, Phuka J, Vosti SA, Zeilani M, Ashorn P.

2015-05-2018 citations

10.3945/jn.114.209593

Interventions

DIETARY_SUPPLEMENTLipid-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

DIETARY_SUPPLEMENTLipid-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

DIETARY_SUPPLEMENTLipid-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

DIETARY_SUPPLEMENTLipid-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

DIETARY_SUPPLEMENTLipid-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

DIETARY_SUPPLEMENTMaize-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

167 Days to 197 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)
Incidence of caregiver-reported morbidity	Daily assessment during 12 month supplementation
Immune function (measured by humoral immunity towards measles vaccination)	12 months after enrollment (age 18 months)
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)
Proportion with anaemia at 18 months of age	12 months after enrollment (age 18 months)
Change in erythrocyte essential fatty acid (EFA) concentration (measured from a subsample of 400 participants)	12 months after enrollment (age 18 months)
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
Incidence of all adverse events during the study period	12 months after enrollment (age 18 months)
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)
Incidence of stunting, underweight, and wasting	Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)

Countries

Malawi

Outcome results

None listed