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

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Burkina Faso
Study Type
Interventional
Intervention
LNS-Zn5
LNS-Zn10
LNS-Zn0
Suppl-Zn5
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring point-of-use fortification, zinc supplement, lipid-based nutrient supplement, zinc deficiency, micronutrient deficiency, anemia

Eligibility Criteria

9 Months - 9 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 9.0 to 9.9 mo of age

Exclusion Criteria:

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

Sites / Locations

  • Institut de Recherche en Sciences de la Sante

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

No Intervention

Arm Label

LNS-Zn5

LNS-Zn10

LNS-Zn0

Suppl-Zn5

Delayed intervention group

Arm Description

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

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

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

Daily intake of zinc supplement containing 5 mg of zinc and 20 g LNS containing 0 mg of zinc

Standard care from age 8 to 18 months. Daily consumption of LNS from age 18 to 28 months.

Outcomes

Primary Outcome Measures

Change in length and length-for-age Z-score
Change in weight and weight-for-age Z-score
Incidence of diarrhea and laboratory-confirmed malaria infection
Change in plasma zinc concentration
Change in body composition

Secondary Outcome Measures

Change in head circumference and mid-upper arm circumference
Change in stunting, underweight, and wasting
Change in hemoglobin, iron, vitamin A and iodine status
Incidence of acute lower respiratory infection (ALRI)

Full Information

First Posted
July 21, 2009
Last Updated
July 11, 2018
Sponsor
University of California, Davis
Collaborators
Université Polytechnique de Bobo-Dioulasso
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1. Study Identification

Unique Protocol Identification Number
NCT00944281
Brief Title
Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Université Polytechnique de Bobo-Dioulasso

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
point-of-use fortification, zinc supplement, lipid-based nutrient supplement, zinc deficiency, micronutrient deficiency, anemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LNS-Zn5
Arm Type
Experimental
Arm Description
Daily intake of 20 g LNS containing 5 mg of zinc and a daily placebo supplement
Arm Title
LNS-Zn10
Arm Type
Experimental
Arm Description
Daily intake of 20 g LNS containing 10 mg of zinc and a daily placebo supplement
Arm Title
LNS-Zn0
Arm Type
Placebo Comparator
Arm Description
Daily intake of 20 g LNS containing 0 mg of zinc and a daily placebo supplement
Arm Title
Suppl-Zn5
Arm Type
Experimental
Arm Description
Daily intake of zinc supplement containing 5 mg of zinc and 20 g LNS containing 0 mg of zinc
Arm Title
Delayed intervention group
Arm Type
No Intervention
Arm Description
Standard care from age 8 to 18 months. Daily consumption of LNS from age 18 to 28 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
LNS-Zn5
Other Intervention Name(s)
Nutriset
Intervention Description
Daily consumption of 20 g LNS containing 5 mg of zinc and daily placebo supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
LNS-Zn10
Other Intervention Name(s)
Nutriset
Intervention Description
Daily consumption of 20 g LNS containing 10 mg of zinc and daily placebo supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
LNS-Zn0
Other Intervention Name(s)
Nutriset
Intervention Description
20 g of LNS containing 0 mg of zinc and a daily placebo supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Suppl-Zn5
Other Intervention Name(s)
Nutriset
Intervention Description
Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc
Primary Outcome Measure Information:
Title
Change in length and length-for-age Z-score
Time Frame
9 to 18 mo of age
Title
Change in weight and weight-for-age Z-score
Time Frame
9 to 18 mo of age
Title
Incidence of diarrhea and laboratory-confirmed malaria infection
Time Frame
9 to 18 mo of age
Title
Change in plasma zinc concentration
Time Frame
9 to 18 mo of age
Title
Change in body composition
Time Frame
9 to 18 mo of age
Secondary Outcome Measure Information:
Title
Change in head circumference and mid-upper arm circumference
Time Frame
9 to 18 mo of age
Title
Change in stunting, underweight, and wasting
Time Frame
9 to 18 mo of age
Title
Change in hemoglobin, iron, vitamin A and iodine status
Time Frame
9 to 18 mo of age
Title
Incidence of acute lower respiratory infection (ALRI)
Time Frame
9 to 18 mo of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 9.0 to 9.9 mo of age Exclusion Criteria: severe anemia severely malnourished presence of bipedal oedema severe illness congenital abnormalities chronic medical condition known HIV infection of mother or infant history of peanut allergy history of anaphylaxis or serious allergic reaction to any substance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Dewey, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kenneth H Brown, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Recherche en Sciences de la Sante
City
Bobo-Dioulasso
Country
Burkina Faso

12. IPD Sharing Statement

Citations:
PubMed Identifier
25816354
Citation
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.
Results Reference
result
PubMed Identifier
26362661
Citation
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.
Results Reference
result
PubMed Identifier
26411504
Citation
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.
Results Reference
result
PubMed Identifier
28152989
Citation
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.
Results Reference
result
PubMed Identifier
28771493
Citation
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.
Results Reference
result
PubMed Identifier
25521188
Citation
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.
Results Reference
result
PubMed Identifier
35829783
Citation
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.
Results Reference
derived
PubMed Identifier
27474016
Citation
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.
Results Reference
derived
PubMed Identifier
26962193
Citation
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.
Results Reference
derived
Links:
URL
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0122242
Description
PLoS ONE: Small-quantity lipid-based nutrient supplements...

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

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