AzTrials
AzTrials

MalnutritionNCT00944281

Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS)

A study testing LNS-Zn5, LNS-Zn10 and LNS-Zn0 in people with Malnutrition, run by University of California, Davis at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To assess zinc-related biochemical and functional responses among young Burkinabe children with a presumed high risk of zinc deficiency who receive micronutrient products containing different amounts of zinc, provided with or between meals. Read more about this study

Who is it for?
Ages 9 to 9 monthsHealthy volunteers can take part
Conditions the study is for
Malnutrition
What is being tested?
LNS-Zn5, LNS-Zn10 and LNS-Zn0
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,220 participants
Where
1 siteBurkina Faso
Study dates
May 2010to Dec 2014
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 9 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 9.0 to 9.9 mo of age

Who cannot join

  • severe anemia
  • severely malnourished
  • presence of bipedal oedema
  • severe illness
  • congenital abnormalities
  • chronic medical condition
Show all 9Show fewer
  • known HIV infection of mother or infant
  • history of peanut allergy
  • history of anaphylaxis or serious allergic reaction to any substance

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

  • Institut de Recherche en Sciences de la Sante

    Bobo-Dioulasso

Other trials in Burkina Faso

About this study

Official title: A Randomized, Double-blind, Controlled Trial in Rural Burkina Faso to Determine the Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS). Part of the iLiNS Study

To assess zinc-related biochemical and functional responses among young Burkinabe children with a presumed high risk of zinc deficiency who receive micronutrient products containing different amounts of zinc, provided with or between meals.

Read the detailed description

Young healthy children will be identified by periodic consensus in the study area. 3200 infants meeting a set of eligibility criteria will be randomly assigned to receive lipid-based nutrient supplements (LNS) with different amounts of zinc and a placebo or zinc supplement from 9 to 18 months of age. The families will receive the respective supplement at weekly intervals and the participants undergo a morbidity evaluation weekly, anthropometric evaluation at 9, 12, 15 and 18 months and laboratory analyses at enrollment and at 18 months of age. Growth outcomes will be analyzed during the two-year follow up at 24, 30, 36 and 42 months of age.

Conditions
Malnutrition
Being tested
LNS-Zn5, LNS-Zn10, LNS-Zn0, Suppl-Zn5
Keywords
point-of-use fortification, zinc supplement, lipid-based nutrient supplement, zinc deficiency, micronutrient deficiency, anemia
Medical subject headings
Malnutrition, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LNS-Zn5Dietary supplement

    Also called Nutriset

    Daily consumption of 20 g LNS containing 5 mg of zinc and daily placebo supplement

  • LNS-Zn10Dietary supplement

    Also called Nutriset

    Daily consumption of 20 g LNS containing 10 mg of zinc and daily placebo supplement

  • LNS-Zn0Dietary supplement

    Also called Nutriset

    20 g of LNS containing 0 mg of zinc and a daily placebo supplement

  • Suppl-Zn5Dietary supplement

    Also called Nutriset

    Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc

Study groups in NCT00944281
Study groupRoleWhat they receive
LNS-Zn5ExperimentalDaily intake of 20 g LNS containing 5 mg of zinc and a daily placebo supplement
Receives: Dietary Supplement: LNS-Zn5
LNS-Zn10ExperimentalDaily intake of 20 g LNS containing 10 mg of zinc and a daily placebo supplement
Receives: Dietary Supplement: LNS-Zn10
LNS-Zn0Placebo comparatorDaily intake of 20 g LNS containing 0 mg of zinc and a daily placebo supplement
Receives: Dietary Supplement: LNS-Zn0
Suppl-Zn5ExperimentalDaily intake of zinc supplement containing 5 mg of zinc and 20 g LNS containing 0 mg of zinc
Receives: Dietary Supplement: Suppl-Zn5
Delayed intervention groupNo interventionStandard care from age 8 to 18 months. Daily consumption of LNS from age 18 to 28 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in length and length-for-age Z-score

    Measured: 9 to 18 mo of age

  2. Change in weight and weight-for-age Z-score

    Measured: 9 to 18 mo of age

  3. Incidence of diarrhea and laboratory-confirmed malaria infection

    Measured: 9 to 18 mo of age

  4. Change in plasma zinc concentration

    Measured: 9 to 18 mo of age

  5. Change in body composition

    Measured: 9 to 18 mo of age

Secondary outcomes (4)

  1. Change in head circumference and mid-upper arm circumference

    Measured: 9 to 18 mo of age

  2. Change in stunting, underweight, and wasting

    Measured: 9 to 18 mo of age

  3. Change in hemoglobin, iron, vitamin A and iodine status

    Measured: 9 to 18 mo of age

  4. Incidence of acute lower respiratory infection (ALRI)

    Measured: 9 to 18 mo of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2009 (estimated)
  2. Study startMay 2010
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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
3,220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00944281
Sponsor's protocol ID
236850
Other IDs
iLiNS-Zinc
Status last verified
Jul 2018
First submitted
21 Jul 2009
Last updated
13 Jul 2018
Results posted
No
Data monitoring committee
No

Publications

  • Hess SY, Abbeddou S, Jimenez EY, Some JW, Vosti SA, Ouedraogo ZP, Guissou RM, Ouedraogo JB, Brown KH. Small-quantity lipid-based nutrient supplements, regardless of their zinc content, increase growth and reduce the prevalence of stunting and wasting in young burkinabe children: a cluster-randomized trial. PLoS One. 2015 Mar 27;10(3):e0122242. doi: 10.1371/journal.pone.0122242. eCollection 2015.

    PubMed 25816354

  • Some JW, Abbeddou S, Yakes Jimenez E, Hess SY, Ouedraogo ZP, Guissou RM, Vosti SA, Ouedraogo JB, Brown KH. Effect of zinc added to a daily small-quantity lipid-based nutrient supplement on diarrhoea, malaria, fever and respiratory infections in young children in rural Burkina Faso: a cluster-randomised trial. BMJ Open. 2015 Sep 11;5(9):e007828. doi: 10.1136/bmjopen-2015-007828.

    PubMed 26362661

  • Hess SY, Abbeddou S, Yakes Jimenez E, Ouedraogo JB, Brown KH. Iodine status of young Burkinabe children receiving small-quantity lipid-based nutrient supplements and iodised salt: a cluster-randomised trial. Br J Nutr. 2015 Dec 14;114(11):1829-37. doi: 10.1017/S0007114515003554. Epub 2015 Sep 28.

    PubMed 26411504

  • Abbeddou S, Yakes Jimenez E, Some JW, Ouedraogo JB, Brown KH, Hess SY. Small-quantity lipid-based nutrient supplements containing different amounts of zinc along with diarrhea and malaria treatment increase iron and vitamin A status and reduce anemia prevalence, but do not affect zinc status in young Burkinabe children: a cluster-randomized trial. BMC Pediatr. 2017 Feb 2;17(1):46. doi: 10.1186/s12887-016-0765-9.

    PubMed 28152989

  • Hess SY, Peerson JM, Becquey E, Abbeddou S, Ouedraogo CT, Some JW, Yakes Jimenez E, Ouedraogo JB, Vosti SA, Rouamba N, Brown KH. Differing growth responses to nutritional supplements in neighboring health districts of Burkina Faso are likely due to benefits of small-quantity lipid-based nutrient supplements (LNS). PLoS One. 2017 Aug 3;12(8):e0181770. doi: 10.1371/journal.pone.0181770. eCollection 2017.

    PubMed 28771493

  • Abbeddou S, Hess SY, Yakes Jimenez E, Some JW, Vosti SA, Guissou RM, Ouedraogo JB, Brown KH. Comparison of methods to assess adherence to small-quantity lipid-based nutrient supplements (SQ-LNS) and dispersible tablets among young Burkinabe children participating in a community-based intervention trial. Matern Child Nutr. 2015 Dec;11 Suppl 4(Suppl 4):90-104. doi: 10.1111/mcn.12162.

    PubMed 25521188

  • Abbeddou S, Jimenez EY, Hess SY, Some JW, Ouedraogo JB, Brown KH. Small-quantity lipid-based nutrient supplements, with or without added zinc, do not cause excessive fat deposition in Burkinabe children: results from a cluster-randomized community trial. Eur J Nutr. 2022 Dec;61(8):4107-4120. doi: 10.1007/s00394-022-02936-6. Epub 2022 Jul 13.

    PubMed 35829783

  • 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.

    PubMed 27474016

  • Prado EL, Abbeddou S, Yakes Jimenez E, Some JW, Ouedraogo ZP, Vosti SA, Dewey KG, Brown KH, Hess SY, Ouedraogo JB. Lipid-Based Nutrient Supplements Plus Malaria and Diarrhea Treatment Increase Infant Development Scores in a Cluster-Randomized Trial in Burkina Faso. J Nutr. 2015 Apr 1;146(4):814-822. doi: 10.3945/jn.115.225524.

    PubMed 26962193

Questions about this trial

What is this clinical trial studying?

A study testing LNS-Zn5, LNS-Zn10 and LNS-Zn0 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 9 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 13 Jul 2018. 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?

Change in length and length-for-age Z-score (time frame: 9 to 18 mo of age). The study lists 5 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 NCT00944281, which also lists 9 linked publications.

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 13 Jul 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in