Anemia Clinical Trial
Official title:
Double Fortified Salt Intervention and Work Performance (Productivity) of Women Plantation Workers in West Bengal, India
The main objective of the present study is to assess the impact of double fortified salt
containing iron and iodine on work performance (productivity) of women plantation workers in
India. Efficacy studies have shown that salt double-fortified with iodine and iron can
significantly reduce the incidence rates of iron-deficiency anemia (IDA) and
iodine-deficiency disorders. Double-fortified salt (DFS) can be prepared by mixing
microencapsulated iron compounds into conventionally iodated salt (Yuan et al, 2008). Iron
deficiency anemia affects the work productivity and physical activity. Many studies have
shown that when the individuals with low Hb received iron supplement, their work performance
improved markedly. Animal studies have demonstrated that iron deficient anemic rats had a
lower work tolerance as measured by oxygen consumption than the adult rats with normal Hb
levels (Ohira et al, 1981). Several human studies have demonstrated the effect of iron
supplementation on endurance capacity and work productivity in women (Zhu and Haas, 1997,
1998; Edgerton et al., 1979). Many human studies have also examined the possible linkages
between iron deficiency and concurrent cognitive or behavioral outcomes. Iron
supplementation effective in reducing iron-deficiency anemia would also result in better
behavioral and developmental outcome. Many studies found that IDA had a great influence on
cognitive functions in infants and school children (Lozoff et al., 2003, 1998 and Friel et
al., 2003). However, studies of IDA and cognitive function in adults are few and
controversial.
This study will assess iron status and physical and mental performance at 2 time points,
before and after approximately 10 months during which a controlled intervention will take
place on tea estates at the Panighatta Tea Garden near Siliguri, West Bengal. Subjects will
be women between 18 and 50 years of age who are actively employed as full time tea pickers.
The study requires that 2 experimental groups of subjects be identified: a) an experimental
group that consumes double fortified salt (DFS) containing iron + iodine, and b) a control
group that consumes only iodized salt (IS).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT03341338 -
Genes-in-Action - Hepcidin Regulation of Iron Supplementation
|
||
Completed |
NCT00060398 -
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05384691 -
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
|
Phase 2 | |
Not yet recruiting |
NCT06309641 -
Methemoglobinemia Following Intravenous Iron Treatment
|
||
Completed |
NCT03822884 -
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT02912494 -
A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
Completed |
NCT02912533 -
A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
Completed |
NCT02930850 -
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
|
N/A | |
Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
Completed |
NCT02603250 -
Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
|
N/A | |
Completed |
NCT02384122 -
Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias
|
Phase 3 | |
Completed |
NCT02176759 -
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
|
N/A | |
Withdrawn |
NCT01934842 -
A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
|
N/A | |
Completed |
NCT01922479 -
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
|
Phase 4 | |
Completed |
NCT02310113 -
Transfusion and Skeletal Muscle Tissue Oxygenation
|
N/A | |
Completed |
NCT01693029 -
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
|
Phase 3 | |
Completed |
NCT01458028 -
Age and Gender Effects on the Pharmacokinetics of BAY85-3934
|
Phase 1 | |
Completed |
NCT01432717 -
Study of ACE-536 in Healthy Postmenopausal Women
|
Phase 1 |