Zinc Absorption From SQ-LNS With and Without Phytase
关键词
抽象
日期
最后验证: | 02/28/2018 |
首次提交: | 01/20/2016 |
提交的预估入学人数: | 01/27/2016 |
首次发布: | 01/28/2016 |
上次提交的更新: | 03/19/2018 |
最近更新发布: | 03/21/2018 |
实际学习开始日期: | 04/17/2017 |
预计主要完成日期: | 07/18/2017 |
预计完成日期: | 12/26/2017 |
状况或疾病
干预/治疗
Dietary Supplement: lipid-based nutrient supplement SQ-LNS
Dietary Supplement: lipid-based nutrient supplement SQ-LNS with phytase
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
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: lipid-based nutrient supplement SQ-LNS • Small quantity lipid nutrient supplement SQ-LNS containing 6 mg iron and 8 mg zinc per 20 g sachet (per day) 0.9 mg isotopically enriched 67Zn,0.30 mg isotopically enriched 70Zn, 0.60 mg non-enriched zinc delivered orally in sugar solution
1 mg isotopically enriched 68Zn intravenously | Dietary Supplement: lipid-based nutrient supplement SQ-LNS Small quantity lipid nutrient supplement (SQ-LNS) containing 6 mg iron and 8 mg zinc per 20 g sachet (per day |
Experimental: lipid-based nutrient supplement SQ-LNS with phytase • Small quantity lipid nutrient supplement SQ-LNS containing 6 mg iron and 8 mg zinc per 20 g sachet (per day). Exogenous phytase (projected concentration ~500 FTU/20 g SQ-LNS added during manufacturing 0.9 mg isotopically enriched 67Zn,0.30 mg isotopically enriched 70Zn, 0.60 mg non-enriched zinc delivered orally in sugar solution
1 mg isotopically enriched 68Zn intravenously | Dietary Supplement: lipid-based nutrient supplement SQ-LNS with phytase • Small quantity lipid nutrient supplement (SQ-LNS) containing 6 mg iron and 8 mg zinc per 20 g sachet (per day). Exogenous phytase (projected concentration ~500 FTU/20 g SQ-LNS) added during manufacturing |
资格标准
有资格学习的年龄 | 18 Months 至 18 Months |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | 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 |
结果
主要结果指标
1. Fractional absorption of zinc [10 days]
次要成果指标
1. Total absorption of zinc [10 days]