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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Université Polytechnique de Bobo-Dioulasso
Helen Keller International
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00944281
First received: July 21, 2009
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Malnutrition
Dietary Supplement: LNS-Zn5
Dietary Supplement: LNS-Zn10
Dietary Supplement: LNS-Zn0
Dietary Supplement: Suppl-Zn5
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Change in length and length-for-age Z-score [ Time Frame: 9 to 18 mo of age ] [ Designated as safety issue: No ]
  • Change in weight and weight-for-age Z-score [ Time Frame: 9 to 18 mo of age ] [ Designated as safety issue: No ]
  • Incidence of diarrhea and laboratory-confirmed malaria infection [ Time Frame: 9 to 18 mo of age ] [ Designated as safety issue: No ]
  • Change in plasma zinc concentration [ Time Frame: 9 to 18 mo of age ] [ Designated as safety issue: No ]
  • Change in body composition [ Time Frame: 9 to 18 mo of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in head circumference and mid-upper arm circumference [ Time Frame: 9 to 18 mo of age ] [ Designated as safety issue: No ]
  • Change in stunting, underweight, and wasting [ Time Frame: 9 to 18 mo of age ] [ Designated as safety issue: No ]
  • Change in hemoglobin, iron, vitamin A and iodine status [ Time Frame: 9 to 18 mo of age ] [ Designated as safety issue: No ]
  • Incidence of acute lower respiratory infection (ALRI) [ Time Frame: 9 to 18 mo of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 3200
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   9 Months to 9 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Helen Keller International
Investigators
Study Director: Kathryn Dewey, PhD University of California, Davis
Principal Investigator: Kenneth H Brown, MD University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00944281     History of Changes
Other Study ID Numbers: 236850, iLiNS-Zinc
Study First Received: July 21, 2009
Last Updated: December 7, 2012
Health Authority: Burkina Faso: Ministry of Health

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014