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Iron Deficiency clinical trials

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NCT ID: NCT04721964 Completed - Clinical trials for Iron Deficiency Anemia

Evaluation of the Effects of Routine Iron Supplementation in Children on Gastrointestinal Iron Losses

Start date: February 25, 2021
Phase: N/A
Study type: Interventional

Iron deficiency anaemia (IDA) is common among infants and young children in sub-Saharan Africa.Oral iron administration is usually recom-mended as cost effective measure to prevent and treat iron deficiency (ID) and IDA during childhood. In Kenya, national nutrition policies for anaemia prevention recommend a daily dose of 3-6 mg ele-mental iron per kg body weight if a child is diagnosed with anaemia. Using a novel technology, recent research found increased iron losses during iron supplementation. In an explorative analysis of stool samples collected from Gambian toddlers (Speich et al., 2020), an increase in faecal iron losses during iron supplementation was reported. The present study is aiming to analyse a relationship between routine iron supplementation and increased faecal occult blood losses in 24 Kenyan children with anaemia and iron deficiency in a more structured manner. Secondary objectives of the study are to measure and monitor iron and inflammatory status during the course of the study and to quantify long-term iron absorption and iron losses during a 12-weeks iron supplementation period, in order to put iron balance into relationship to occurring faecal occult blood losses during such an intervention.

NCT ID: NCT04713943 Completed - Iron-deficiency Clinical Trials

Efficacy of >Your< Iron Syrup Supplementation in Children With Dietary Iron Deficiency

IRON-SI
Start date: December 22, 2017
Phase: N/A
Study type: Interventional

The study evaluates the efficacy and safety of >Your< Iron Syrup, a novel iron-containing dietary supplement, in the management of dietary iron deficiency in children. The study is a randomized, double-blind, placebo-controlled intervention conducted in 16 research centers in Slovenia, collectively enrolling 92 eligible children. Eligibility of children for participation in the study will be determined by screening for hemoglobin and ferritin (combined with C-reactive protein) levels in a sample of capillary blood. Eligible children will receive basic dietary advice on how to increase the consumption of dietary iron and will be invited to participate in the study. Enrolled children will be randomized to either >Your< Iron Syrup arm or to placebo arm in a 3:1 ratio, respectively. Changes in body iron stores (ferritin) and in hematological indices as well as occurence of any adverse events will be monitored after 4 and 12 weeks of once-daily supplementation with either >Your< Iron Syrup or placebo.

NCT ID: NCT04705662 Completed - Clinical trials for Iron Deficiency Anemia

GI Effects of Iron in Healthy Volunteers

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Over recent years there has been a lot of research looking at how the bacteria in our gut affects our health. Some medications are known to cause changes in gut bacteria. Many patients that are prescribed iron report gastrointestinal side effects. This research project aims to see if the cause of the gastrointestinal side effects is due to iron causing changes in the gut bacteria. This can be detected via measuring the levels of hydrogen and methane and other compounds in the breath and stool.

NCT ID: NCT04699045 Completed - Iron-deficiency Clinical Trials

Prenatal Iron Status and Its Association With Cord Blood and Infant Ferritin Level

Start date: January 2014
Phase:
Study type: Observational

Iron deficiency (ID) in early life is associated with significant morbidities. Most fetal iron required for infant growth is acquired in the third trimester from maternal iron store. However, how prenatal iron level affects newborn's ferritin level at birth and in early infancy remains controversial. This study aimed to examine the associations between maternal ferritin levels with cord blood serum ferritin (CBSF) and to compare the ferritin levels between different feeding practices in early infancy.

NCT ID: NCT04632771 Completed - Anemia Clinical Trials

Nutritional Status and Bouillon Use in Northern Ghana

Start date: October 19, 2020
Phase:
Study type: Observational

This pilot aims to generate data that are critical for informing the design of a planned, more detailed study to evaluate the effect of multiple micronutrient (MN)-fortified bouillon cube on biomarkers of nutrient status of women and children. Data collection includes measures of nutritional status and dietary intake among women and children and their households in communities in northern Ghana.

NCT ID: NCT04623918 Completed - Anemia Clinical Trials

Iron-Biofortified Rice Intervention in the Philippines

Start date: June 1, 2002
Phase: N/A
Study type: Interventional

The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. A randomized trial of biofortified rice (IR68144-2B-2-2-3), bred to enhance iron content, was conducted among women living in convents in the greater area of Manila, Philippines for 9 months.

NCT ID: NCT04618289 Completed - Iron-deficiency Clinical Trials

Effect of Vitamin D3-fortified Fruit Juice on Iron Status in Women

Start date: August 14, 2021
Phase: N/A
Study type: Interventional

The present study is designed to utilise vitamin D3 supplements that may potentially act as an iron absorption enhancer to improve iron status in the Malaysian child-bearing aged women with low iron stores. In addition to investigating the efficacy, this study is also designed to assess the effect of a dose of vitamin D3 (4000 IU) on iron metabolism. The study will include the measurement of plasma hepcidin and 25(OH)D concentrations to investigate a possible mechanism that links vitamin D and iron deficiency, as postulated from the existing literature. For that reason, the aim of the study was to investigate the effect of an 8-week vitamin D3 supplementation on iron status indicators, including hepcidin concentration in childbearing aged Malaysian women with marginal iron stores. It is hypothesised that there will be a significant improvement in haematological indicators following 8-week daily vitamin D3 supplementation in the vitamin D group compared to placebo group. It is also hypothesised that plasma hepcidin concentration will be reduced following 8-week daily vitamin D3 supplementation, which results in increased iron stores.

NCT ID: NCT04602247 Completed - Iron Deficiency Clinical Trials

Evaluation of Iron Bioavailability From Iron Chlorophyllin

Start date: October 26, 2020
Phase: N/A
Study type: Interventional

The overall objective of this study is to evaluate the iron absorption from iron chlorophyllin. Iron deficiency is a public health problem in both developing and industrialized countries. There are several approaches to combat iron deficiency. Most supplements in the present day, to address the problem of iron deficiency, are in the form of iron salts, known as ferrous salts, especially ferrous sulfate. However, we can only usually absorb about 20% of the total iron content in ferrous sulfate. The common strategy of food supplement companies is to increase the amount of iron in the supplements to compensate for the low absorption rate. However, this often causes gastrointestinal side effects. In the present study, we would like to measure the iron bioavailability from sodium iron chlorophyllin, which made up from ferrous salts and chlorophyllin and where we hypothesize that it is absorbed via a different pathway than ferrous sulfate. Via this mechanism, we further hypothesize that sodium iron chlorophyllin will therefore have an enhanced bioavailability and more favorable side effect profile than ferrous sulfate and other iron salts.

NCT ID: NCT04510831 Completed - Iron-deficiency Clinical Trials

Measuring Dietary Iron Absorption From Edible Insects and Assessing the Effect of Chitin Content on Iron Bioavailability (Study 1)

Sustironable1
Start date: October 26, 2020
Phase: N/A
Study type: Interventional

Due to the growing world population, there is a need to develop viable ecological and nutritional alternatives to animal food products. However, animal products are a key dietary source of well-absorbed iron, and iron deficiency and iron deficiency anemia remain highly prevalent in high- and low-income countries. Meat and fish provide a substantial proportion of absorbed iron in the western diet by two distinct components: a) heme iron is well absorbed (20-45% fractional absorption) and is not affected by most dietary enhancers and inhibitors, which often affect non-heme iron absorption; b) peptides in muscle meat exert an enhancing effect the absorption of non-heme iron contained in other meal components. The potential of edible insects as a dietary source of well-absorbed iron has not been investigated in detail. In particular, it is unclear whether insects provide an iron moiety similar to hemoglobin which would be well absorbed and unaffected by other dietary components, and whether their presence in a test meal exerts an enhancing effect on iron bioavailability from the whole meal. Furthermore, chitin, a major component of insect biomass, is a known iron binder and is potentially responsible for a decreased iron absorption from insect-based foods. Decreasing chitin content could allow the high amounts of iron in insects to be well-absorbed, and enhance the absorption of iron from plant-based foods. To differentiate iron absorption from insect biomass from other sources, insects will be intrinsically labelled with the stable iron isotope 57Fe, while other food iron components will be labelled with the iron isotope 58Fe.The present study will provide novel data to elucidate the nutritional value as sources of dietary iron of insect species (Tenebrio molitor). Since 2017 T.molitor is recognised as an edible insect in the Swiss food legislation and commercially available (Essento Food AG, Zürich; Insekterei, GmbH, Zürich).

NCT ID: NCT04458662 Completed - Inflammation Clinical Trials

Iron and Muscular Damage: FEmale Metabolism and Menstrual Cycle During Exercise

IronFEMME
Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

This project is an observational controlled randomized counterbalance study. One hundred and three physically active and healthy women were selected to participate in the IronFEMME Study, of which 57 were eumenorrheic, 30 were oral contraceptive users (OCP) and 16 were postmenopausal women. The project consisted on two sections carrying out at the same time: Iron metabolism (Study I) and Muscle damage (Study II). For the study I, the exercise protocol consisted on an interval running test (8 bouts of 3 min at 85% of the maximal aerobic speed), whereas the study II protocol was based on an eccentric-based resistance exercise protocol (10 sets of 10 repetitions of plate-loaded barbell parallel back squats at 60% of their 1RM with 2 min of rest between sets). In both studies, eumenorrheic participants were evaluated at three specific moments of the menstrual cycle: Early-follicular phase, late-follicular phase and mid-luteal phase; OCP performed the trial at two moments: Withdrawal phase and active pill phase. Lastly, postmenopausal women were tested only once, since their hormonal status does not fluctuate. The three-step method was used to verify the menstrual cycle phase: calendar counting, blood analyses confirmation and urine-based ovulation kits. Blood samples were obtained to measure sexual hormones (e.g., 17β-Estradiol, Progesterone), iron metabolism parameters (e.g., Hepcidin, Iron, Ferritin, Transferrin) and muscle damage related markers (e.g., Creatine Kinase, Myoglobin, Lactate Dehydrogenase).