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Iron Deficiency clinical trials

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NCT ID: NCT05950841 Not yet recruiting - Iron-deficiency Clinical Trials

Safety and Effectiveness of IHAT in Iron Deficient Pre-menopausal Woman

Start date: January 1, 2024
Phase: Phase 3
Study type: Interventional

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed IHAT (iron hydroxide adipate tartrate) at 2 different doses compared to placebo for increasing serum ferritin levels in iron-deficient but otherwise healthy premenopausal women over 12 weeks.

NCT ID: NCT05913414 Recruiting - Anemia Clinical Trials

Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma

Start date: May 5, 2023
Phase: Phase 2
Study type: Interventional

Primary purposeļ¼š To evaluate the difference of hematopoietic response rate at 1 month after concurrent chemoradiotherapy between iron isomaltide and oral iron supplement for treating iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma. Secondary purpose: To evaluate the difference of hematopoietic response rate, tolerance, acute side effects, qualtiy of life at 2 months and 3 months after concurrent chemoradiotherapy between Iron Isomaltide and oral iron supplement for treating iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma.

NCT ID: NCT05893901 Completed - Iron-deficiency Clinical Trials

Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Rural Niger Villages

NigerMPS
Start date: March 13, 2023
Phase:
Study type: Observational [Patient Registry]

The primary hypothesis is that introduction of food-to-food fortified products through a rural Hub-and-Spoke incubator system contributes to an improved food environment and availability of micronutrients to these communities. A secondary hypothesis is that the influence of the rural Spokes can serve to enhance rural food environments through creation of secondary rural spokes that disseminate improved food-to-food fortified products. The overall hypothesis is that a product designed with optimized nutritional characteristics, based on consumer preferences and leveraging local nutrient dense ingredients, can successfully deliver nutrition through sustainable market-driven approaches.

NCT ID: NCT05882682 Completed - Iron-deficiency Clinical Trials

Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Eldoret, Kenya

KenyaMPS
Start date: October 20, 2022
Phase:
Study type: Observational [Patient Registry]

The overall hypotheses is that a product designed with optimized nutritional characteristics, based on consumer preferences and leveraging local nutrient dense ingredients, can successfully deliver nutrition through sustainable market-driven approaches. The objectives of this study will be 1) to assess the nutritional adequacy of Kenyan households with children and 2) to determine the market potential of a locally sourced and manufactured, blended fortified, cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months. This study will simulate a market study, the investigators conducted a product launch, determined market potential based on sales, evaluated marketing strategy to increase market share, and modeled the nutritional contribution of FtFF/traditionally fortified product for iron, zinc, and vitamin A. The investigators expect to provide a throughout evaluation of a business-driven strategy (for profit, social enterprise) as a sustainable tool to decrease micronutrient deficiencies.

NCT ID: NCT05872061 Completed - Iron-deficiency Clinical Trials

Senegal Market Study for Food-to-Food Fortified (F2F) Instant Porridge Flours

SenegalMPS
Start date: January 27, 2022
Phase:
Study type: Observational

The overall hypotheses is that a product designed with optimized nutritional characteristics, based on consumer preferences and leveraging local nutrient dense ingredients, can successfully deliver nutrition through sustainable market-driven approaches. The objectives of this study were 1) to assess the nutritional adequacy of urban Senegalese households with children and 2) to determine the market potential of a locally sourced and manufactured, blended fortified, cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months. This study simulates a market study, the investigators will conduct a product launch, determine market potential based on sales, evaluate marketing strategy to increase market share, and model the nutritional contribution of FtFF/traditionally fortified product for iron, zinc, and vitamin A. The investigators expect to provide a thorough evaluation of a business-driven strategy (for profit, social enterprise) as a sustainable tool to decrease micronutrient deficiencies.

NCT ID: NCT05816265 Enrolling by invitation - Heart Failure Clinical Trials

Effects of IV Iron Replacement on Exercise Capacity in Individuals With Heart Failure

Start date: January 24, 2024
Phase: Phase 4
Study type: Interventional

Patients with heart failure with reduced ejection fraction and iron deficiency will be randomized to either receive iron infusion or be in the control group. The study is looking at how iron replacement affects exercise capacity as measured by peak oxygen uptake.

NCT ID: NCT05788172 Completed - Anemia Clinical Trials

Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique

MBL_Loss
Start date: March 1, 2023
Phase:
Study type: Observational

It is very difficult to quantify menstrual blood loss, the reference method is a tedious one. This is a problem, as it is not conducive to objectively measuring menstrual blood loss and understanding the contribution of menstrual iron loss to iron deficiency anemia. With this study, the investigators aim to investigate iron loss during the menstrual cycle and aim to validate a much simpler technique.

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: NCT05750940 Enrolling by invitation - Iron-deficiency Clinical Trials

Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency

FERRIFY
Start date: October 5, 2021
Phase:
Study type: Observational [Patient Registry]

Observational study using in vivo noninvasive 31 phosphor magnetic resonance spectroscopy (31P MRS) to quantify the effect of iron deficiency (ID) on skeletal oxidative metabolism in patients with chronic heart failure (HF).

NCT ID: NCT05702970 Not yet recruiting - Heart Failure Clinical Trials

Beneficial Effects of Vitamin D Combined With Oral Iron Supplementation in Patients With Chronic Heart Failure and Iron Deficiency

VICTORID-HF
Start date: January 15, 2024
Phase: Phase 4
Study type: Interventional

The goal of this randomized, controlled, open-label, interventional study is to evaluate whether, in patients with heart failure (HF) and iron deficiency (ID), the administration of vitamin D in combination with sucrosomial iron is as effective as intravenous ferric carboxymaltose in improving symptoms of HF. The main hypothesis which the study aims to test is the non-inferiority of sucrosomial iron (± vitamin D) compared with FCM treatment, after 24 weeks. Primary endpoint: the performance of the Six-Minute Walking Test, comparing the mean difference from baseline of the distance walked by patients in meters. Participants will be evaluated in outpatient scheduled visits at 6, 12 and 24 weeks, performing blood tests, clinical evaluation, instrumental investigations and recording any adverse events, cardiovascular events, re-hospitalizations and fractures. The study will involve randomization into 3 groups with a 1:1:1 ratio: 1. Control group [standard of care]: administration of FCM (Ferinject®) with a dose between 500 and 2000 mg (depending on body weight and hemoglobin values), to be administered in 1 or 2 doses (time 0 ± 6 weeks) with possible additional administration of 500 mg at week 12 in case of persistent ID. 2. Sucrosomial iron group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once a day for 24 weeks. 3. Sucrosomial iron and vitamin D group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once daily + vitamin D3 (100,000 IU load at time 0, then 2,000 IU daily) for 24 weeks