Optimal Amount of Zinc to Include in a Lipid-based Nutrient Supplement (LNS)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, Davis
Collaborators:
Institut de Recherche en Sciences de la Sante, 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
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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
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
Institut de Recherche en Sciences de la Sante, 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 May 23, 2013