Zinc Absorption From SQ-LNS With and Without Phytase

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02668133
• Date of registration: 21/01/2016
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: Zinc Absorption From SQ-LNS With and Without Phytase
• Scientific title: Efficacy of Exogenous Phytase Added to Small Quantity Lipid Nutrient Supplements (SQ-LNS) on the Fractional and Total Absorption of Zinc Among Young Children in the Gambia: A Double-blind Randomized Controlled Trial With a Cross-over Design
• Date of first enrolment: April 18, 2017
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02668133
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Gambia

Contacts

• Name: Andrew Prentice, PhD
• Affiliation: Medical Research Council The Gambia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent from at least one parent, including consent for samples to be
shipped outside of The Gambia

- Age 18-23 months

- non-breast feeding children and consumption of coos porridge

- Previous consumption of peanut based products with no known adverse reaction

Exclusion Criteria:

- Weight-for-height z-score (WHZ) <-3 Z with respect to WHO 2006 standards*

- Presence of bipedal oedema

- Severe illness warranting hospital referral

- Congenital abnormalities potentially interfering with micronutrient metabolism

- Chronic medical condition (e.g. malignancy) requiring frequent medical attention

- Known HIV infection of index child or child's mother

- Currently consuming vitamin or mineral supplements or zinc- or iron-fortified infant
formulas/foods

- Diarrhoea (>3 liquid or semi-liquid stools per day) within the past 7 days

- Symptomatic acute or chronic febrile infection within the past 7 days

- Hemoglobin < 70 g/L*

- Positive rapid diagnostic test for malaria antigenemia (HRP2)* * Exclusion criteria
for main metabolic study only (not criteria for the pilot feeding study, as
anthropometric and biochemical data will not be collected



Age minimum: 18 Months
Age maximum: 23 Months
Gender: All

Health Condition(s) or Problem(s) studied

Individuals at Risk of Zinc Deficiency

Intervention(s)

Dietary Supplement: lipid-based nutrient supplement (SQ-LNS) with phytase

Dietary Supplement: the nutritional supplement to be used in this trial is a SQ-LNS

Dietary Supplement: 0.9 mg isotopically enriched 67Zn,0.30 mg isotopically enriched 70Zn, 0.60 mg non-enriched zinc

Dietary Supplement: 1 mg isotopically enriched 68Zn

Primary Outcome(s)

Fractional absorption of zinc [Time Frame: 10 days]

Secondary Outcome(s)

Total absorption of zinc [Time Frame: 10 days]

Secondary ID(s)

SCC 1420

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of California, Davis