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

May 26, 2015 updated by: Per Ashorn, Tampere University

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1920

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Mangochi, Malawi
        • University of Malawi, College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 months to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
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
Time Frame: 12 months after enrollment (age 18 months)
12 months after enrollment (age 18 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)
Incidence of stunting, underweight, and wasting
Time Frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)
Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)
Prevalence of reduced appetite
Time Frame: Daily assessment during 12 month supplementation
Daily assessment during 12 month supplementation
Energy intake from complementary foods
Time Frame: 3 and 9 months after enrollment (age 9 and 15 months)
3 and 9 months after enrollment (age 9 and 15 months)
Incidence of laboratory-confirmed malaria infection
Time Frame: 12 months after enrollment (age 18 months)
12 months after enrollment (age 18 months)
Incidence of caregiver-reported morbidity
Time Frame: Daily assessment during 12 month supplementation
Daily assessment during 12 month supplementation
Immune function (measured by humoral immunity towards measles vaccination)
Time Frame: 12 months after enrollment (age 18 months)
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
Time Frame: 12 months after enrollment (age 18 months)
12 months after enrollment (age 18 months)
Proportion with anaemia at 18 months of age
Time Frame: 12 months after enrollment (age 18 months)
12 months after enrollment (age 18 months)
Change in erythrocyte essential fatty acid (EFA) concentration (measured from a subsample of 400 participants)
Time Frame: 12 months after enrollment (age 18 months)
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)
Time Frame: Limited assessment every 4 weeks during the 12 months supplementation, more comprehensive at age 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
Time Frame: 12 months after enrollment (age 18 months)
12 months after enrollment (age 18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tampere University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Davis
Bill and Melinda Gates Foundation
Kamuzu University of Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth Maleta, MBBS, PhD, Kamuzu University of Health Sciences
  • Principal Investigator: Per Ashorn, MD, PhD, University of Tampere Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • iLiNS-DOSE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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