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

Tampere University

Status and phase: Completed; Phase 3

Conditions: Malnutrition

Treatments: Dietary Supplement: Lipid-based Nutrient Supplement, 20gNoM; Dietary Supplement: Lipid-based Nutrient Supplement, 40gNoM; Dietary Supplement: Maize-soy flour; Dietary Supplement: Lipid-based nutrient supplement, 40gM; Dietary Supplement: Lipid-based nutrient supplement, 20gM; Dietary Supplement: Lipid-based nutrient supplement, 10gM

Study type: Interventional

Funder types: Other

Identifiers

NCT00945698

iLiNS-DOSE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,920 estimated patients

Sex: All

Ages: 167 to 197 days old

Volunteers: Accepts 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,920 participants in 6 patient groups

ST-DI (Delayed intervention)

Other group

Description:

* 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

Treatment:

Dietary Supplement: Maize-soy flour

LNS-10gM

Experimental group

Description:

* 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

Treatment:

Dietary Supplement: Lipid-based nutrient supplement, 10gM

LNS-20gM

Experimental group

Description:

* 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

Treatment:

Dietary Supplement: Lipid-based nutrient supplement, 20gM

LNS-20gNoM

Experimental group

Description:

* 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

Treatment:

Dietary Supplement: Lipid-based Nutrient Supplement, 20gNoM

LNS-40gM

Experimental group

Description:

* 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

Treatment:

Dietary Supplement: Lipid-based nutrient supplement, 40gM

LNS-40gNoM

Experimental group

Description:

* 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

Treatment:

Dietary Supplement: Lipid-based Nutrient Supplement, 40gNoM