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

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ClinicalTrials.gov Identifier: NCT00944281
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
Université Polytechnique de Bobo-Dioulasso
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: LNS-Zn5 Dietary Supplement: LNS-Zn10 Dietary Supplement: LNS-Zn0 Dietary Supplement: Suppl-Zn5 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : May 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LNS-Zn5
Daily intake of 20 g LNS containing 5 mg of zinc and a daily placebo supplement
Dietary Supplement: LNS-Zn5
Daily consumption of 20 g LNS containing 5 mg of zinc and daily placebo supplement
Other Name: Nutriset

Experimental: LNS-Zn10
Daily intake of 20 g LNS containing 10 mg of zinc and a daily placebo supplement
Dietary Supplement: LNS-Zn10
Daily consumption of 20 g LNS containing 10 mg of zinc and daily placebo supplement
Other Name: Nutriset

Placebo Comparator: LNS-Zn0
Daily intake of 20 g LNS containing 0 mg of zinc and a daily placebo supplement
Dietary Supplement: LNS-Zn0
20 g of LNS containing 0 mg of zinc and a daily placebo supplement
Other Name: Nutriset

Experimental: Suppl-Zn5
Daily intake of zinc supplement containing 5 mg of zinc and 20 g LNS containing 0 mg of zinc
Dietary Supplement: Suppl-Zn5
Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc
Other Name: Nutriset

No Intervention: Delayed intervention group
Standard care from age 8 to 18 months. Daily consumption of LNS from age 18 to 28 months.



Primary Outcome Measures :
  1. Change in length and length-for-age Z-score [ Time Frame: 9 to 18 mo of age ]
  2. Change in weight and weight-for-age Z-score [ Time Frame: 9 to 18 mo of age ]
  3. Incidence of diarrhea and laboratory-confirmed malaria infection [ Time Frame: 9 to 18 mo of age ]
  4. Change in plasma zinc concentration [ Time Frame: 9 to 18 mo of age ]
  5. Change in body composition [ Time Frame: 9 to 18 mo of age ]

Secondary Outcome Measures :
  1. Change in head circumference and mid-upper arm circumference [ Time Frame: 9 to 18 mo of age ]
  2. Change in stunting, underweight, and wasting [ Time Frame: 9 to 18 mo of age ]
  3. Change in hemoglobin, iron, vitamin A and iodine status [ Time Frame: 9 to 18 mo of age ]
  4. Incidence of acute lower respiratory infection (ALRI) [ Time Frame: 9 to 18 mo of age ]


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Ages Eligible for Study:   9 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944281


Locations
Burkina Faso
Institut de Recherche en Sciences de la Sante
Bobo-Dioulasso, Burkina Faso
Sponsors and Collaborators
University of California, Davis
Université Polytechnique de Bobo-Dioulasso
Investigators
Study Director: Kathryn Dewey, PhD University of California, Davis
Principal Investigator: Kenneth H Brown, MD University of California, Davis

Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00944281     History of Changes
Other Study ID Numbers: 236850
iLiNS-Zinc
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Keywords provided by University of California, Davis:
point-of-use fortification
zinc supplement
lipid-based nutrient supplement
zinc deficiency
micronutrient deficiency
anemia

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs