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Effect of Vitamin E Supplementation on Hemoglobin Levels in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02181348
Recruitment Status : Completed
First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Tanveer Jilani, Aga Khan University

Brief Summary:

Anemia is one of the major health problems of the developing countries of the world [1]. According to the WHO reference criteria, an adult is labeled as anemic, if the blood hemoglobin concentration falls below 13.0 g/dL in men or less than 12.0 g/dL in the non-pregnant women [2]. Hemoglobin concentrations below the lower limit of normal are a common laboratory finding in apparently healthy people in general population all over the world [3-5]. Many of these mildly anemic individuals are not investigated sufficiently to establish the probable cause of their anemia and thus may end up with morbidity and health problems, especially the young women in developing countries [4].

Only few studies on the use of vitamin E in the correction of anemia have been published and hardly any on correction of mild anemia in healthy adults. The objective of this intervention study was to investigate the association of vitamin E supplementation with post-supplemental blood hemoglobin levels in mildly anemic healthy Pakistani adults.


Condition or disease Intervention/treatment Phase
Anemia Drug: Vitamin E Drug: placebo (edible oil) Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Role of Vitamin E in Enhancing Erythropoiesis and the Molecular Mechanism of the Action of Vitamin E on Erythropoietin-secreting Cells
Study Start Date : November 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011


Arm Intervention/treatment
Active Comparator: Intervention (Vitamin E supplementation)
Vitamin E 400 mg once daily for 3 months
Drug: Vitamin E
dl-alpha tocopheryl acetate 400 mg once daily for 3 months
Other Name: Evion

Placebo Comparator: placebo (edible oil) Drug: placebo (edible oil)



Primary Outcome Measures :
  1. Change in hemoglobin levels [ Time Frame: Change in hemoglobin levels in mildly anemic adults at baseline and after 3 months of intervention (vitamin E or placebo) in all the participants in intervention arm and placebo arm (end-line). ]
    Hemoglobin levels in blood were determined in mildly anemic adults before intervention (baseline) and after 3 months of supplementation with vitamin E 400 mg per day (end-line).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • mildly anemic (on the basis of screening) volunteer males and non-pregnant and non-lactating females, giving written informed consent.
  • normolipidemic, normotensive
  • no history of: i. diabetes, hyperlipidemia, obesity, asthma, cancer, respiratory, cardiovascular, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, sexually-transmitted disease, during the last 5 years.

ii. severe acute or chronic blood loss during last 6 months. iii. bleeding or clotting abnormality during last 1 year. iv. regular cigarette smoking, tobacco chewing v. consumption of vitamin E, vitamin B12, folate, iron or antioxidant during the last 6 months prior to enrollment.

Exclusion Criteria:

  • pregnant and lactating females.
  • cigarette smoking, tobacco chewing, alcohol consumers
  • blood transfusions during the last 1 year
  • history of diabetes mellitus, hypertension, dyslipidemia , obesity asthma, cancer, respiratory, renal, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, cardiovascular disorder/disease during the last five years.
  • severe acute blood loss during last 6 months.
  • bleeding or clotting abnormalities during the last 1 year.
  • consumed vitamin E, B12, folate, iron or antioxidants supplements during the last 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181348


Locations
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Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Dr. Tanveer Jilani, MBBS, M.Phil Aga Khan University

Publications:
1. Milman N (2011) Ann Hematol 90:369-377. 2. WHO (2011) Vitamins and Mineral Nutrition Information System. Geneva, World Health Organization, (WHO/NMH/NHD/MNM/11.1). 2,2014) 3. Bulliyy G, Mallick G, Sethy GS, Kar SK (2007) Int J Adolesc Med Health 19(4): 395-406. 4. Kusumi E, Shoji M, Endou S, Kishi Y, Shibata T, et al. (2006) Int J Hematol 84(3): 217-219. 5. Ziauddin Hyder S, Persson LK, Chowdhury A, Ekstrom EC (2001) Public Health Nutr 4(1): 79-83. 6. Ahmed J, Zaman MM, Ali K (2003) Mymensingh Med J 12(2): 120-123. 7. Gogu SR, Lertora JJ, George WJ, Hyslop NE, Agrawal KC (1991) Exp Hematol 19: 649-652. 8. Jaja SI, Aigbe PE, Gbenebitse S, Temiye EO (2005) Niger Postgrad Med J 12: 110-114. 9. Sultana N, Begum N, Begum S, Ferdousi S, Ali T (2009) Pak J Physiol 5(1):25-28.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Tanveer Jilani, Senior Instructor, Aga Khan University
ClinicalTrials.gov Identifier: NCT02181348     History of Changes
Other Study ID Numbers: TJilani
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014

Keywords provided by Dr. Tanveer Jilani, Aga Khan University:
Vitamin E, Hemoglobin, mild anemia

Additional relevant MeSH terms:
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Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents