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

NCT00944281 | Completed

• 2 other identifiers: 236850iLiNS-Zinc
• Study Type: interventional
• Target: 3,220
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

point-of-use fortification; zinc supplement; lipid-based nutrient supplement; zinc deficiency; micronutrient deficiency; anemia

Outcome Measures

Primary Outcomes (5)

• Change in length and length-for-age Z-score

  9 to 18 mo of age

• Change in weight and weight-for-age Z-score

  9 to 18 mo of age

• Incidence of diarrhea and laboratory-confirmed malaria infection

  9 to 18 mo of age

• Change in plasma zinc concentration

  9 to 18 mo of age

• Change in body composition

  9 to 18 mo of age

Secondary Outcomes (4)

• Change in head circumference and mid-upper arm circumference

  9 to 18 mo of age

• Change in stunting, underweight, and wasting

  9 to 18 mo of age

• Change in hemoglobin, iron, vitamin A and iodine status

  9 to 18 mo of age

• Incidence of acute lower respiratory infection (ALRI)

  9 to 18 mo of age

Study Arms (5)

LNS-Zn5

EXPERIMENTAL

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

Dietary Supplement: LNS-Zn5

LNS-Zn10

EXPERIMENTAL

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

Dietary Supplement: LNS-Zn10

LNS-Zn0

PLACEBO COMPARATOR

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

Dietary Supplement: LNS-Zn0

Suppl-Zn5

EXPERIMENTAL

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

Dietary Supplement: Suppl-Zn5

Delayed intervention group

NO INTERVENTION

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

Interventions

LNS-Zn5 DIETARY_SUPPLEMENT

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

Also known as: Nutriset

LNS-Zn5

LNS-Zn10 DIETARY_SUPPLEMENT

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

Also known as: Nutriset

LNS-Zn10

LNS-Zn0 DIETARY_SUPPLEMENT

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

Also known as: Nutriset

LNS-Zn0

Suppl-Zn5 DIETARY_SUPPLEMENT

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

Also known as: Nutriset

Suppl-Zn5

Eligibility Criteria

• Age: 9 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 9.9 mo of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Université Polytechnique de Bobo-Dioulasso: collaborator

Study Sites (1)

Institut de Recherche en Sciences de la Sante

Bobo-Dioulasso, Burkina Faso

Location

Related Publications (9)

• 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.

  PMID: 25816354 RESULT

• 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.

  PMID: 26362661 RESULT

• 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.

  PMID: 26411504 RESULT

• 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.

  PMID: 28152989 RESULT

• 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.

  PMID: 28771493 RESULT

• 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.

  PMID: 25521188 RESULT

• 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.

  PMID: 35829783 DERIVED

• 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.

  PMID: 27474016 DERIVED

• 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.

  PMID: 26962193 DERIVED

Related Links

• PLoS ONE: Small-quantity lipid-based nutrient supplements...

MeSH Terms

Conditions

Malnutrition; Anemia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kathryn Dewey, PhD

  University of California, Davis

  STUDY DIRECTOR

• Kenneth H Brown, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 23, 2009
• Study Start: May 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

BU (1)