MalnutritionNCT00944814
Acceptability of Zinc-fortified Lipid-based Nutrient Supplements
A study testing LNS with zinc and LNS without zinc in people with Malnutrition, run by University of California, Davis at 1 site in Burkina Faso.
Trial summary
The purpose of the study is to assess the acceptability of the two lipid-based nutrient supplement (LNS) formulations containing no zinc and a high amount of zinc (10 mg zinc / 20 g dose of LNS). The hypothesis is that both products will be equally accepted by children and mothers. Read more about this study
- Who is it for?
- Ages 9 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- LNS with zinc and LNS without zinc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Jul 2009to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Currently breast-feeding and consuming complementary foods for at least 30 d
Who cannot join
- Height-for-age and weight-for height Z-scores <-3 with respect to WHO growth standards
- Edema
- Diarrhea and other diseases that could interfere with food intake
- Severe systemic illness
- History of peanut allergy
- History of anaphylaxis/serious allergic reaction
- Infants meeting these criteria and their mother's will be invited to participate
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Institut de Recherche en Sciences de la Santé
Bobo-Dioulasso
About this study
Official title: Assessment of the Acceptability of Zinc-fortified Lipid Based Nutrient (LNS) Prepared for Young Burkinabe Children
The purpose of the study is to assess the acceptability of the two lipid-based nutrient supplement (LNS) formulations containing no zinc and a high amount of zinc (10 mg zinc / 20 g dose of LNS). The hypothesis is that both products will be equally accepted by children and mothers.
Read the detailed description
We plan to conduct a series of acceptability studies to: 1) assess the amounts of zinc-free and high-zinc LNS consumed by children during direct observation, 2) compare their mothers' sensory assessments of the respective products, and 3) review maternal reports of their child feeding experiences during more prolonged home feeding trials.
- Conditions
- Malnutrition
- Being tested
- LNS with zinc, LNS without zinc
- Keywords
- Lipid-based nutrient supplement, Prevention of malnutrition, Prevention of micronutrient deficiencies, Zinc
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNS with zincDietary supplement
Also called Nutriset lipid-based nutrient supplement with zinc
Lipid-based nutrient supplement (LNS) containing 10 mg zinc/20 g LNS dose
LNS without zincDietary supplement
Also called Nutriset lipid-based nutrient supplement without zinc
LNS containing no zinc
| Study group | Role | What they receive |
|---|---|---|
| LNS with zinc | Experimental | LNS containing 10 mg zinc per 20 g dose of LNS Receives: Dietary Supplement: LNS with zinc |
| LNS without zinc | Placebo comparator | LNS containing no zinc Receives: Dietary Supplement: LNS without zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of each type of LNS formulation consumed by young children
Measured: 3 days
Preference and detection of differences between LNS formulations among mothers
Measured: 3 days
Acceptability of feeding LNS to young children at home
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Université Polytechnique de Bobo-Dioulasso, Helen Keller International, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Kenneth H. Brown, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944814
- Sponsor's protocol ID
- 200917273
- Other IDs
- iLiNS-ACCEPT-Zinc
- Status last verified
- Feb 2017
- First submitted
- 21 Jul 2009
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hess SY, Bado L, Aaron GJ, Ouedraogo JB, Zeilani M, Brown KH. Acceptability of zinc-fortified, lipid-based nutrient supplements (LNS) prepared for young children in Burkina Faso. Matern Child Nutr. 2011 Oct;7(4):357-67. doi: 10.1111/j.1740-8709.2010.00287.x. Epub 2010 Dec 15.
PubMed 21159124
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Acceptability of Zinc-fortified Lipid Based Nutrient (LNS) Prepared for Young Burkinabe Children
- ClinicalTrials.gov ID
- NCT00944814
- Acronym / sponsor ID
- 200917273
- Conditions
- Malnutrition
- Keywords
- Lipid-based nutrient supplement, Prevention of malnutrition, Prevention of micronutrient deficiencies, Zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Université Polytechnique de Bobo-Dioulasso, Helen Keller International, Bill and Melinda Gates Foundation
- Study start
- Jul 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the acceptability of the two lipid-based nutrient supplement (LNS) formulations containing no zinc and a high amount of zinc (10 mg zinc / 20 g dose of LNS). The hypothesis is that both products will be equally accepted by children and mothers.
Detailed description
We plan to conduct a series of acceptability studies to: 1) assess the amounts of zinc-free and high-zinc LNS consumed by children during direct observation, 2) compare their mothers' sensory assessments of the respective products, and 3) review maternal reports of their child feeding experiences during more prolonged home feeding trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNS with zinc | Experimental | Dietary Supplement: LNS with zincLNS containing 10 mg zinc per 20 g dose of LNS |
| LNS without zinc | Placebo comparator | Dietary Supplement: LNS without zincLNS containing no zinc |
Who may qualify
- Ages
- 9 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Currently breast-feeding and consuming complementary foods for at least 30 d
Key exclusion criteria (7 listed)
- Height-for-age and weight-for height Z-scores <-3 with respect to WHO growth standards
- Edema
- Diarrhea and other diseases that could interfere with food intake
- Severe systemic illness
- History of peanut allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNS with zincAlso: Nutriset lipid-based nutrient supplement with zincLipid-based nutrient supplement (LNS) containing 10 mg zinc/20 g LNS dose | Dietary supplement | LNS with zinc |
| LNS without zincAlso: Nutriset lipid-based nutrient supplement without zincLNS containing no zinc | Dietary supplement | LNS without zinc |
Primary outcome
Amount of each type of LNS formulation consumed by young children
Time frame: 3 days
Preference and detection of differences between LNS formulations among mothers
Time frame: 3 days
Acceptability of feeding LNS to young children at home
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Results publication: PubMed 21159124Hess SY, Bado L, Aaron GJ, Ouedraogo JB, Zeilani M, Brown KH. Acceptability of zinc-fortified, lipid-based nutrient supplements (LNS) prepared for young children in Burkina Faso. Matern Child Nutr. 2011 Oct;7(4):357-67. doi: 10.1111/j.1740-8709.2010.00287.x. Epub 2010 Dec 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth H. Brown, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LNS with zinc and LNS without zinc in people with Malnutrition, run by University of California, Davis at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of each type of LNS formulation consumed by young children (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00944814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.