Testing Iron Absorption From a New Micronutrient Powder Containing Galacto-oligosaccharides (GOS) for Fortification of Infant Foods in Sub-Saharan Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change from baseline in isotopic ratio of iron in blood at day 18 and 19 for Study 1 and 2 respectively
研究概览
简要总结
Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA by ensuring that the iron needs of infants and young children are met without changing their traditional diet. In order to optimize iron absorption timing of MNP consumption might as well be important. This is because hepcidin, a key regulator of systemic iron balance, shows a circadian increase that may influence morning versus afternoon iron absorption from the MNP. Furthermore, a single dose of iron can increase hepcidin levels and potentially inhibit iron absorption from a second dose, consumed close in time to the first dose.
To determine the difference between i) morning versus afternoon iron absorption and ii) consecutive versus alternate day iron absorption, investigators will enrol 20 infants from Kwale County aged 6-14 months and conduct two studies. In study 1, infants will consume 2 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate in the morning and afternoon on 2 days. In study 2, infants will consume 3 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate on two consecutive days and 1 alternate day. In both studies, fourteen days after the last test meal administration, a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and inflammation status parameter will be determined at baseline and endpoint. Hepcidin concentrations will be measured before the morning and afternoon meals (study 1) and after second consecutive meal (study 2).
Knowing the effect of time on the expected iron absorption will inform decisions on the ideal timing of MNP to cover the infant's requirement for absorbed iron.
详细描述
20 infants will be recruited from the Msambweni County Referral Hospital in southern coastal Kenya to participate in both studies.
Study 1:
At baseline a morning blood sample will be collected from potential study participants for the determination of the following iron and inflammation status parameters: hemoglobin (Hb), hepcidin, plasma ferritin (PF), soluble transferrin receptor (sTfR), zinc protoporphyrin (ZnPP), C-reactive protein (CRP), alpha-1-acid glycoprotein (AGP). Anthropometrics (height, weight, mid-upper arm and head circumference) will be measured, and demographics, the medical history and the feeding habits will be assessed using a questionnaire.
Infants will consume the 1st test meal the next day after enrolment in the morning (day1). On day 2 a 2nd blood sample (1ml) will be collected in the afternoon quantify afternoon concentration of hepcidin in plasma and then the infants will consume the 2nd meal on the 3rd day in the afternoon.
The two isotopically labelled test meals will be fed to the infants by their caregivers under supervision of the research team. The morning test meal A will contain 12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe. The afternoon test meal will contain 12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10 mg of 56Fe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 14 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 6-14 months at baseline
- •Assessment of good health as assessed by health professional staff at Msambweni County Referral Hospital
- •Willingness of their caregiver to provide informed consent
排除标准
- •Hemoglobin <70 g/L; these infants will be referred for treatment according to local standard of care
- •Severe underweight (Z-score weight-for-age <-3) and /or severe wasting (Z-score weight-for-height<-3)
- •Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- •Participants taking part in other studies requiring the drawing of blood
- •Participants who are taking iron-containing food supplements or tablets/drops
研究组 & 干预措施
Study 1:Morning test meal+Iron+MNP
The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous Fumarate and 2.5 mg Fe as NaFeEDTA, maltodextrin carrier (added up to 11g). Iron compound added to the morning test meal A:12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe.
Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron)
干预措施: Fortified maize porridge (MNP and Iron) (Dietary Supplement)
Study 1:Afternoon test meal+Iron+MNP
The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous Fumarate and 2.5 mg Fe as NaFeEDTA, maltodextrin carrier (added up to 11g). Iron compound added to the afternoon test meal B:12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10mg of 56Fe.
Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron)
干预措施: Fortified maize porridge (MNP and Iron) (Dietary Supplement)
Study 2: Consecutive meals+Iron+MNP+GOS
The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous Fumarate and 2.5 mg Fe as NaFeEDTA, plus 7.5 g of galacto-oligosaccharides given as 10.5 g GOS-75, maltodextrin carrier (added up to 11g) Iron compound added to the test meals:Test meal A will contain 12mg of ferrous sulphate given as 2mg 54Fe and 10mg 56Fe. Test meal B will contain 12mg of ferrous sulphate given as 2mg 57Fe and 10mg 56Fe.
Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS)
干预措施: Fortified Maize porridge (MNP + Iron + GOS) (Dietary Supplement)
Study 2:Alternate meal+Iron+MNP+GOS
The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous fumarate and 2.5 mg Fe as NaFeEDTA, plus 7.5 g of galacto-oligosaccharides given as 10.5 g GOS-75, maltodextrin carrier (added up to 11g) Iron compound added to the test meal C: 12mg of ferrous sulphate given as 2mg 58Fe and 10mg.
Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS)
干预措施: Fortified Maize porridge (MNP + Iron + GOS) (Dietary Supplement)
结局指标
主要结局
Change from baseline in isotopic ratio of iron in blood at day 18 and 19 for Study 1 and 2 respectively
时间窗: Baseline and day 18, baseline and day 19
次要结局
- Hepcidin concentration(Baseline and day 3, and day 2 for study 1 and 2 respectively)
- Iron status(Baseline and days 18 and 19 for study 1 and 2 respectively)
- Inflammation status(Baseline and days 18 and 19 for study 1 and 2 respectively)