Advertisement

Topics

Directly Observed Iron Supplementation to Treat Anemia

2014-08-27 03:13:27 | BioPortfolio

Summary

India continues to be one of the countries with very high prevalence of anemia. In fact, National Family Health Survey-3 (NFHS-3,2005-06) revealed increasing prevalence of anemia in women and children, since NFHS-2 in 1998-99. In the backdrop of this alarming trend, the aim of this trial is to assess the effectiveness of a community based anemia management intervention ( curative and holistic) delivered to rural anemia women and girls(aged 13 years and above)in remote hilly villages (unit of randomization) in terms of change in anemia prevalence (unit of analysis) after 3 months of iron supplementation. This trial with a therapeutic component of "Directly Observed Home Based daily Iron Therapy (DOHBIT)" by local village volunteers is conceived as a whole community approach to improve the hemoglobin status of affected patients in remote villages.

Description

To combat iron deficiency anemia, the challenge is not so much knowing "what" to do, but to understand "how" to implement effective and sustainable interventions. In this perspective, the aim of this trial is to assess the effectiveness of a community based anemia management therapeutic intervention delivered to rural anemic women (aged 13 years and above) in remote hilly villages (unit of randomization) in terms of change in anemia prevalence (unit of analysis) after 3 months of iron supplementation.

The intervention programme "Directly Observed Home Based daily Iron Therapy"(DOHBIT) by local village volunteers is conceived as a whole community approach to improve the hemoglobin status of affected patients in remote villages. A cluster-randomized trial will be thus the design of choice from the outset. For intervention arm of trial, each anemic patient will receive DOHBIT (Directly Observed Home Based daily Iron Therapy) by local village volunteer for a total of 90 days whereas in the control arm of trial each patient will receive usual standard iron therapy without daily supervision for the same duration. Information, educational and counseling strategies will be similar for the two groups.

Primary outcome will be the anemia prevalence (difference of proportions) in intervention vs. control groups after trial intervention. Secondary outcomes in two groups include mean hemoglobin levels, compliance and side effects of iron therapy, body mass index and quality of life scores.

Sample size estimates, adjusted for cluster randomization (assuming Intracluster Correlation Coefficient of 0.05 and mean cluster size of 30 patients/village based on our pilot study), show that with 10 villages, each for intervention and control groups, an average 300 anemic patients per treatment arm would need to be treated to provide sufficient power to determine a 20% difference in anemia prevalence in two groups- a reduction deemed to a worthwhile impact of the intervention to be reliably detected at 80% power.

Then a statistically valid approach to the analysis of primary outcome variable will be to calculate a single outcome measure for each randomized unit and apply standard parametric method (chi-square) to the set of summary measures, keeping in mind that any conclusion will be strictly applicable only at the cluster level. Since, covariate adjustment will be required on an individual level for various secondary outcomes, thus a different approach based on the individual, as unit of analysis, adjusting for clustering will be more appropriate in analyzing various secondary outcome measures.

Overall, DOHBIT is one of the strategies to increase the capacity of individuals and communities to define, analyze and act to address their own health needs. Moreover, in the supply-demand continuum, DOHBIT by utilizing facilitators and motivators at the local level will optimize demand as well as supply of iron supplementation programme in the community.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Iron Deficiency Anemia (IDA)

Intervention

Directly observed home based daily iron therapy

Location

Build Healthy India Movement
Sirmaur
Himachal Pradesh
India

Status

Recruiting

Source

Build Healthy India Movement

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:27-0400

Clinical Trials [2287 Associated Clinical Trials listed on BioPortfolio]

Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants

This study compares weekly versus daily administration of iron for prevention of anemia in 6 months old infants. One third of the infants that are exclusively breast fed will not receive i...

Iron Deficiency in Female State Fair Attendees

This study aims to examine iron deficiency symptoms and biochemical iron status based on hemoglobin, hematocrit, ferritin, and total iron binding capacity in menstruating females.

Effects of Polyphenols on Iron Absorption in Iron Overload Disorders.

Dysmetabolic iron overload syndrome and genetic hemochromatosis are frequent causes of iron overload. Polyphenols are efficient iron-chelators. Investigator hypothesize that polyphenol sup...

IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose

The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron pre...

Low-dose Iron Supplementation and Markers of Iron Status Among Non-anemic, Iron-deficient Women

Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose iron dietary supplement. The investigators seek to determine if the low-dose iron dietary supplem...

PubMed Articles [33842 Associated PubMed Articles listed on BioPortfolio]

Positive Iron Balance in Chronic Kidney Disease: How Much is Too Much and How to Tell?

Regulation of body iron occurs at cellular, tissue, and systemic levels. In healthy individuals, iron absorption and losses are minimal, creating a virtually closed system. In the setting of chronic k...

Hepcidin in Iron Homeostasis: Diagnostic and Therapeutic Implications in Type 2 Diabetes Mellitus Patients.

The prevalence of type 2 diabetes is increasing in epidemic proportions worldwide. Evidence suggests body iron overload is frequently linked and observed in patients with type 2 diabetes. Body iron me...

Dietary Factors Modulate Iron Uptake in Caco-2 Cells from an Iron Ingot Used as a Home Fortificant to Prevent Iron Deficiency.

Iron deficiency is a major public health concern and nutritional approaches are required to reduce its prevalence. The aim of this study was to examine the iron bioavailability of a novel home fortifi...

Improvement of chronic hepatitis B by iron chelation therapy in a patient with iron overload: A case report.

This report describes seroconversion of hepatitis B surface antigen (HBsAg) in a patient with marked iron overload caused by chronic hepatitis B (CHB) after receiving iron chelation therapy and discus...

Efficacy of iron supplementation on fatigue and physical capacity in non-anaemic iron-deficient adults: a systematic review of randomised controlled trials.

Iron supplementation in iron-deficiency anaemia is standard practice, but the benefits of iron supplementation in iron-deficient non-anaemic (IDNA) individuals remains controversial. Our objective is ...

Medical and Biotech [MESH] Definitions

Iron or iron compounds used in foods or as food. Dietary iron is important in oxygen transport and the synthesis of the iron-porphyrin proteins hemoglobin, myoglobin, cytochromes, and cytochrome oxidase. Insufficient amounts of dietary iron can lead to iron-deficiency anemia.

A multifunctional iron-sulfur protein that is both an iron regulatory protein and cytoplasmic form of aconitate hydratase. It binds to iron regulatory elements found on mRNAs involved in iron metabolism and regulates their translation. Its rate of degradation is increased in the presence of IRON.

A multifunctional iron-sulfur protein that is both an iron regulatory protein and cytoplasmic form of aconitate hydratase. It binds to iron regulatory elements found on mRNAs involved in iron metabolism and regulates their translation. Its RNA binding ability and its aconitate hydrolase activity are dependent upon availability of IRON.

Anemia characterized by decreased or absent iron stores, low serum iron concentration, low transferrin saturation, and low hemoglobin concentration or hematocrit value. The erythrocytes are hypochromic and microcytic and the iron binding capacity is increased.

An excessive accumulation of iron in the body due to a greater than normal absorption of iron from the gastrointestinal tract or from parenteral injection. This may arise from idiopathic hemochromatosis, excessive iron intake, chronic alcoholism, certain types of refractory anemia, or transfusional hemosiderosis. (From Churchill's Illustrated Medical Dictionary, 1989)

More From BioPortfolio on "Directly Observed Iron Supplementation to Treat Anemia"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...


Searches Linking to this Trial