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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT05762380 Completed - Clinical trials for Iron Deficiency Anemia

Effect of Iron Supplements on the Growth of Enteric Pathogens

Start date: June 14, 2022
Phase: N/A
Study type: Interventional

Iron supplementation is a common approach to address iron deficiency with recommendations for women of childbearing age, particularly those at risk of iron deficiency. Because of its considerably higher absorption, ferrous sulphate is the common iron compound used in iron supplements. However, concerns about iron supplements arise from the knowledge that a large portion of the supplement consumed is not absorbed. This unabsorbed iron travels to the colon and, in preclinical studies, has been shown to promote the growth of enteric pathogens at the expense of beneficial commensal bacteria and increase infection risk, including the clinical incidence of diarrhea. The objective of this study is to compare the effects of iron as ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool samples will be collected from women of reproductive age following ingestion of an iron supplement as either FeSO4 or Ao iron. Stool samples will be spiked with common enteric pathogens, and outcome measures will be determined following in vitro fecal fermentation.

NCT ID: NCT05725278 Completed - Contraception Clinical Trials

Impact Evaluation of Triggerise's Tiko Platform

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Triggerise designed web and phone based Tiko platform to connect young girls and women to the health products, services and information. The platform uses principles of behaviour economics to motivate positive choices-including rewards, promotions, discounts, coupons, reminders, alerts etc. The platform was implemented in several cities from seven states of India to provide Sexual Reproductive Health (SRH) and maternal and child health (MCH) products and services. The consumers (called Rafikis) use Tiko card to get discounts and to earn 'Tiko miles' rewards at Tiko franchised healthcare providers and pharmacies. Tiko miles are redeemable towards lifestyle products or services (e.g., beauty salons). The local Tiko health promoter (celled Pro agent) can also buy health and hygiene products at bulk discounts and sell them at profit. Triggerise appointed Network for Engineering, Economics Research and Management (NEERMAN) to conduct an independent impact assessment of the Tiko platform with multiple research objectives include health impact evaluation at the Rafiki level. NEERMAN used an ex-post observational design to compare usage of SRH and MCH services and family planning (FP), antenatal care (ANC) and postnatal care (PNC) practices by comparing Users and Non-Users of Tiko platform, and accounting for the selection bias statistically. The structured questionnaire collected data on knowledge, practices, barriers, enablers for SRH and MCH services, exposure o Tiko platform, and how it helped or did not help. The survey participants were approx. 1200 users and 600 non-users being served by approx. 350 pro-agents in their respective operations area. The association between use of Tiko platform and various outcomes were identified using a generalized linear model with fixed effects at pro-agent level and including a set of covariates. To evaluate the effect modification by type of pro agent - government community health worker (CHW) versus others - an interaction model was used. The standard errors were automatically clustered at pro-agent level due to fixed effects. Primary outcomes are proportion of married Rafikis currently using any contraceptives, currently using modern short-term contraceptives, proportion of Rafikis who delivered a child post Jan 2019 and received at least 4 ANC check-ups, consumed at least 100 iron folic acid (IFA( during pregnancy, and received a PNC check-up within 6 weeks of birth.

NCT ID: NCT05673161 Completed - Clinical trials for Iron Deficiency Anemia

Retrospective Evaluation of the Effect of Iron (Fe) Infusion on Complications in Anemic Patients Undergoing Thoracotomy

Start date: November 15, 2022
Phase:
Study type: Observational

In patients who underwent thoracotomy due to lung malignancy; It is desired to investigate whether there is a difference in terms of postoperative results between those with and without anemia, and those with iron deficiency anemia (IDA) who underwent intravenous iron replacement and those who did not, according to the hemoglobin value in their preoperative examinations.

NCT ID: NCT05660200 Completed - Iron-deficiency Clinical Trials

Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of an ODF Iron Supplement vs an Iron Supplement in Capsules

Start date: November 25, 2022
Phase: N/A
Study type: Interventional

Open, monocentric, comparative, cross-over study to evaluate the rate and the extent of iron absorption after a single oral dose of (A) IBSA Iron orodispersible film vs (B) SiderAL® FORTE capsules in healthy women aged 18 to 55 years.

NCT ID: NCT05522790 Completed - Colorectal Surgery Clinical Trials

Impact of Iron Infusion in Anemic Patients on Their Postoperative Outcome After Colorectal Surgery

IRON_PREHAB
Start date: May 18, 2022
Phase:
Study type: Observational

In 2005, colorectal surgery in France represented nearly 40,000 procedures per year, of which 80% were scheduled and 70% were for carcinological purposes. Overall postoperative mortality was estimated at 3.4%, morbidity at 35% and average length of stay at 18 days. In addition, the number of newly diagnosed cases of colorectal cancer was 44,872 in 2017, making it the second leading cause of cancer in women and the third in men. The implementation of colorectal Enhanced Rehabilitation After Surgery (EARS) programs has resulted in a significant reduction in length of stay due to an approximately 50% decrease in postoperative complication rates and a faster return of patients to independence. However, despite the integration of RASC into routine practice, morbidity remains high with an estimated complication rate of 15-20%. The persistence of a high complication rate despite the rehabilitation measures can be explained in part by factors present preoperatively that impair postoperative recovery, such as the existence of comorbidities, low functional capacity, the presence of martial or nutritional deficiencies or glycemic imbalance. Links between the presence of these different "deficits", which may coexist, and postoperative morbidity and mortality have already been shown. Anemia is common in preoperative colorectal surgery and affects approximately one in two patients with cancer. In case of preoperative anemia, the frequency of postoperative complications and the length of stay are increased. Under these conditions, preoperative correction of anemia could facilitate postoperative recovery and reduce the incidence of postoperative complications. In colorectal cancer, anemia is the consequence of an absolute martial deficiency due to iron losses from bleeding and a functional martial deficiency due to decreased availability of iron for erythropoiesis due to inflammation. Correction of preoperative anemia is usually based on 2 types of molecules: iron and erythropoiesis stimulating agents. Erythropoiesis-stimulating agents are not recommended to correct anemia in cancer patients not receiving chemotherapy. Iron can be given orally or intravenously. Intravenous administration is more effective than oral administration in patients with colorectal cancer to correct preoperative anemia. In patients undergoing colon cancer surgery outside of a RAAC program, preoperative iron infusion appears to decrease the incidence of postoperative complications, improve the quality of postoperative recovery, and reduce length of stay. These gains do not appear to be related to correction of preoperative anemia, since preoperative intravenous iron increases hemoglobin levels by only 0.8 g/dl, on average. And, insufficiently to reduce the rate of postoperative transfusion in abdominal or general surgery. Also, the benefits observed with preoperative iron infusion seem to be more related to the direct effects of iron on cardiac and skeletal muscle than by correction of anemia. Since 2016, all patients undergoing scheduled colorectal surgery at the Paris Saint Joseph Hospital Group benefit from the application of a RAAC program. If we do not take into account patients who die during hospitalization (≈ 2%) and patients transferred to Follow-up and Rehabilitation Care (SSR) (≈15%), the impact of the application of a RAAC program is easily measured with the length of stay. Indeed, reducing the frequency of postoperative complications and improving the speed of postoperative recovery translates into reduced lengths of stay. Today, the average length of stay for all patients undergoing colorectal surgery at Saint Joseph Hospital is 7.5 days. The length of stay is longer (8.7 days) in patients with anemia preoperatively compared to those without anemia (7 days). Since 2017, anemic patients scheduled for colorectal surgery, have received intravenous iron infusion preoperatively at Paris Saint Joseph Hospital.

NCT ID: NCT05414474 Completed - Clinical trials for Iron Deficiency Anemia

Effects of Enhancers and Inhibitors on Absorption From Iron Supplements

Start date: June 20, 2022
Phase: N/A
Study type: Interventional

Iron deficiency (ID) is a major public health problem worldwide and oral iron supplementation can be an effective strategy to treat and prevent ID. To maximize iron bioavailability form oral iron supplements the simultaneous intake of the iron absorption enhancer ascorbic acid (AA) is recommended, and the simultaneous intake of coffee or tea containing the iron absorption inhibitors polyphenols should be avoided. Also, oral iron supplements are recommended to be taken on an empty stomach in the morning and without a meal to avoid any interaction with phytic acid, another iron absorption inhibitor present in many foods. However, the effects of these iron absorption enhancers and inhibitors have only been shown on iron absorption from dietary iron (up to 10mg). Also, the effect of the diurnal hepcidin increase on absorption from an iron supplement given in the afternoon without a preceding morning dose is unclear. Whether AA also increases iron bioavailability from a supplemental iron dose and whether a cup of coffee, a breakfast or iron administration in the afternoon decreases iron bioavailability from a supplemental dose is uncertain.

NCT ID: NCT05365308 Completed - Clinical trials for Iron-deficiency Anemia

EHR-based Patient Identification and Panel Management of Patients With Iron Deficiency Anemia

Start date: February 28, 2022
Phase: N/A
Study type: Interventional

The objective is to determine if a set of clinical supports that includes computer-assisted identification, an EHR registry, facilitated GI referral, and an EHR tool for documentation improves the timely referral and completion of bidirectional endoscopy in men aged 18 years and older and women aged 40 years and older with iron deficiency anemia.

NCT ID: NCT05314062 Completed - Clinical trials for Iron Deficiency Anemia

Effect of Iron Source on the Growth of Enteric Pathogens

Start date: March 18, 2022
Phase: N/A
Study type: Interventional

The World Health Organization recommends daily iron supplementation for infants and children (6 months-12 years). Based on the low cost and high bioavailability and efficacy, ferrous sulfate is typically the first choice for supplementation and fortification. The recommended dose of iron is set high to deliver adequate absorbed iron due to low rates of dietary iron absorption, which is typically <10%. Thus, the majority of dietary iron is not absorbed and travels to the colon. Unabsorbed iron in the colon may select for enteric pathogens at the expense of beneficial commensal bacteria and increase infection risk, including the clinical incidence of diarrhea. The objective of this study is to compare the effects of iron as ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool samples will be collected from children following ingestion of an iron supplement as either FeSO4 or Ao iron. Stool samples will be spiked with common enteric pathogens and outcome measures will be determined following in vitro fecal fermentation.

NCT ID: NCT05262634 Completed - Iron Deficiency Clinical Trials

Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester

Start date: September 1, 2021
Phase:
Study type: Observational

The primary aim of this retrospective, monocentric study with two parallel groups is to investigate pregnancy outcome in women with iron deficiency in the first trimester. It compares the pregnancy outcome between pregnant women with an iron deficiency and those without an iron deficiency in the first trimester. The study group are pregnant women with a diagnosed iron deficiency in the first trimester, a total of 227 pregnant women. The control group consists of 486 pregnant women without first-trimester iron deficiency. Matching criteria include parity and maternal age. Data from patient files of pregnant women who were treated in the Women's Clinic, University Hospital Basel between 2017 and 2019 are analyzed.

NCT ID: NCT05257343 Completed - Clinical trials for Iron Deficiency (Without Anemia)

Efficacy of a Low Dose, Oral, Liquid Iron Supplement on Restoring Inadequate Blood Iron to Normal Levels

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting constipating side-effects among healthy premenopausal women with non-anemic iron deficiency. The primary outcomes will be an Iron Panel of Serum Iron, Ferritin, Total iron-binding capacity, Transferrin saturation, Complete Blood Count, and high sensitivity - C-Reactive Protein. Secondary outcomes will be surveys on gastrointestinal distress/discomfort and well-being. Adverse events will also be reported.