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

University of California (UC) Davis

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: LNS-Zn0; Dietary Supplement: Suppl-Zn5; Dietary Supplement: LNS-Zn5; Dietary Supplement: LNS-Zn10

Study type: Interventional

Funder types: Other

Identifiers

NCT00944281

236850

iLiNS-Zinc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,220 patients

Sex: All

Ages: 9 to 9 months old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,220 participants in 5 patient groups, including a placebo group

LNS-Zn5

Experimental group

Description:

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

Treatment:

Dietary Supplement: LNS-Zn5

LNS-Zn10

Experimental group

Description:

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

Treatment:

Dietary Supplement: LNS-Zn10

LNS-Zn0

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: LNS-Zn0

Suppl-Zn5

Experimental group

Description:

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

Treatment:

Dietary Supplement: Suppl-Zn5

Delayed intervention group

No Intervention group

Description:

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