Assessment of Gastrointestinal Symptoms and Other Side Effects After Three Week Oral Ferrous Sulfate and Iron-enriched Aspergillus Oryzae Supplementation in Young Female Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Area under the serum iron curve over 8 hours
研究概览
简要总结
The objective of this study is to examine patient-reported gastrointestinal side effects, as well as iron status indicators, inflammatory markers and oxidative stress following administration of ferrous sulfate and iron-enriched Aspergillus oryzae supplementation.
详细描述
Iron deficiency anemia (IDA) afflicts more than 2 billion people globally, making it the most prevalent nutrient disorder, today. Inadequate dietary intake of iron results in consequences like cognitive decline, fatigue, abnormal growth and adverse pregnancy outcomes. These ramifications have associated burdens on economical progression due to decreased market productivity. Inorganic iron supplements like ferrous sulfate (FeSO4) are most commonly used to treat IDA, however known associated side effects occur, decreasing compliancy in individuals. Moreover, inorganic iron salts present a large bolus of iron to the intestinal lumen, resulting in non-transferrin bound iron which leads to systemic inflammation and further exacerbation of chronic diseases. Organic iron compounds have strong potential to be utilized for supplementation, however only under circumstances in which contain high absorbance. Seventeen subjects were randomized in a three-armed, double-blinded crossover design to examine the differences among three treatments (FeSO4, ASP-s and placebo). Outcomes will be to assess acute inflammatory proteins, oxidative stress, iron status indicators, non-transferrin bound iron and gastrointestinal-related side effects.
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
- Double (Participant, Investigator)
盲法说明
Treatments will be randomized to A or B. Investigators will be blinded to the corresponding treatment, in addition to the subjects being randomized to follow the sequence of supplements as ACB or BCA.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-40
- •BMI < 30 kg/m2
- •Nonsmoker
- •Non pregnant
- •Non lactating
- •No food allergies to wheat or dairy
- •No history of gastrointestinal diseases/disorders
- •Willing to discontinue use of vitamin/mineral supplements
- •No medications that interfere with iron absorption
- •No blood or plasma donations during study period
排除标准
- •History of gastrointestinal diseases or disorders
- •Donating blood or plasma two weeks prior to study period
- •On medications interfering with iron absorption
- •Food allergies to wheat or dairy
- •Pregnant or lactating
- •Anemic (< 120 g/L)
- •Ferritin > 40 ug/L
研究组 & 干预措施
Ferrous sulfate
Subjects will take a 65 mg Fe capsule of ferrous sulfate, once daily for 21 consecutive days. The first treatment capsule will be consumed with a semi-purified meal (egg albumin, sugar, vanilla, maltodextrose and corn oil) and will have blood drawn hours 0, 1, 2, 3, 4, 6 and 8 post consumption. Serum will be used to determine non-transerrin bound iron, serum iron and percent saturation. Throughout the treatment period, subjects are informed to consume the capsule with food and report symptoms in an online questionnaire. Following three weeks treatment, participants return for a blood draw and oxidative stress indicators are measured. A three week washout period with placebo treatment takes place between treatment crossover.
干预措施: Ferrous sulfate (Dietary Supplement)
Aspiron
AspironTM which is an iron-enriched supplement will follow the same guidelines and protocol as ferrous sulfate arm. Equivalent 65 mg Fe per capsule will be administered to participants.
干预措施: Aspiron (Dietary Supplement)
Placebo
Participants will follow the same description for the other two experimental treatment groups. Capsules will be given to subjects in opaque formation, therefore will be unable to differentiate the iron supplements.
干预措施: Placebo (Other)
结局指标
主要结局
Area under the serum iron curve over 8 hours
时间窗: 0,1,2,3,4,6 and 8 hours
Serum iron concentrations (µM) measured over 8 hours following consumption of either Ultimine, FeSO4, or placebo capsules at baseline (0h).
Area under the NTBI curve over 8 hours
时间窗: 0,1,2,3,4,6 and 8 hours
NTBI (µM) concentrations measured over 8 hours following consumption of either Ultimine, FeSO4, or placebo capsules at baseline (0h).
Area under the percent transferrin saturation curve over 8 hours
时间窗: 0,1,2,3,4,6 and 8 hours
Percent transferrin (%) saturation concentrations measured over 8 hours following consumption of either Ultimine, FeSO4, or placebo capsules at baseline (0h).
次要结局
- Change in protein carbonyls(Baseline and 21 days)
- Change in hematocrit(Baseline and 21 days)
- Change in soluble transferrin receptor (sTFR)(Baseline and 21 days)
- Change in total iron binding capacity (TIBC)(Baseline and 21 days)
- Change in creatinine(Baseline and 21 days)
- Change in aspartate aminotransferase (AST)(Baseline and 21 days)
- Change in hemoglobin(Baseline and 21 days)
- Change in glomerular filtration rate (eGFR)(Baseline and 21 days)
- Change in thiobarbituric acid reactive substances (TBARS)(Baseline and 21 days)
- Change in hepcidin(Baseline and 21 days)
- Change in C-reactive protein(Baseline and 21 days)
- Change in serum ferritin(Baseline and 21 days)
- Change in blood urea nitrogen (BUN)(Baseline and 21 days)
- Change in alanine aminotransferase (ALT)(Baseline and 21 days)
- Gastrointestinal symptoms(21 days)
研究者
Dr. Manju B. Reddy
Professor
Iowa State University