Effect of Vitamin E Supplementation on Hemoglobin Levels in Healthy Adults
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      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].

      A few human studies during the past few years have suggested the possible use of antioxidant
      vitamins in the correction of anemia [6]. Vitamin E is an essentially required lipophilic
      vitamin with a variety of antioxidant and non-antioxidant functions. It has been shown that
      treatment with vitamin E resulted in increased number of colony forming units of erythroid
      precursors in experimental animals and protected their bone marrow against drug- induced
      toxicity [7]. In some of the clinical trials in patients with hematological disorders,
      vitamin E supplementation showed decrease in red blood cell deformability and enhanced blood
      hemoglobin levels [8,9]. Although clinical benefits of vitamin E on increasing hemoglobin
      levels in some disease states have been published, yet its effect on a presumably healthy
      adult population with no abnormality other than mild anemia has hardly been reported.

      Hypothesis:

      Vitamin E supplementation for three months to mildly anemic healthy adults (with no past
      history of any iron supplements) would result into improved post-supplemental levels of blood
      hemoglobin compared to their basal levels.

      Objective of the present study: To investigate the association of vitamin E supplementation
      in mildly anemic healthy adults with the post-supplemental blood hemoglobin levels in a
      general population of Karachi, Pakistan.

      Study Participants

      In this placebo-controlled and single blinded study, 357 healthy volunteer subjects, 235
      males and 122 non-pregnant females of age 18-45 years were recruited and enrolled through
      general practitioners' (GP) clinics from various localities of Karachi and from the personnel
      of the Aga Khan University, Karachi. The recruitment was started in 2008 and completed in
      2011. The clinical examination of study subjects was carried out by a general physician. The
      participants were nonsmokers; had no history of gastrointestinal disorders or chronic disease
      or iron deficiency during the last 6 months; had not taken vitamin E supplements or received
      blood transfusion during the past 6 months, and were not dehydrated. They were screened for
      the presence of mild anemia (10.0-13.9 g/dL, in males and 8.4-11.2 g/dL, in non-pregnant
      females using the criteria followed by the Aga Khan University Hospital (AKUH), Karachi.

      After screening, 124 subjects (80 males and 44 females) who were found to be mildly anemic
      and fulfilling the criteria were included in the intervention trial. Eighty two subjects were
      randomly placed in Intervention group and 42 in the Control group.

      Supplementation

      Intervention group: Each subject was provided with 400 mg oral capsule of vitamin E (Evion,
      containing dl-alpha tocopheryl acetate) and was asked to take one capsule daily continuously
      for three months.

      Control group: Each subject was provided with placebo (edible oil) capsules to be taken once
      daily for three consecutive months. The placebo capsules were identical to vitamin E capsules
      in size, shape, color, appearance and taste. The compliance of the participants was monitored
      by counting the number of capsules consumed after every 4 weeks.

      Blood Sampling and Measurement of Biomarkers

      Ten mL of fasting blood was collected before the start of supplementation from each
      participant and another sample (10 mL) was obtained after 3 months of supplementation. Each
      blood sample was divided into two equal parts; one part of blood was transferred to a tube
      containing anticoagulant , while the other part was transferred to a plain tube for obtaining
      serum. Blood samples were analyzed for blood hemoglobin levels in an automated hematology
      analyzer. Serum/plasma samples were kept frozen at -70 degree Centigrade for analysis of
      other biomarkers.
    

Intervention name(s): Vitamin E; placebo (edible oil)
Intervention type(s): Drug; Drug
Intervention description(s): dl-alpha tocopheryl acetate 400 mg once daily for 3 months
Other intervention name(s): Evion
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Vitamin E, Hemoglobin, mild anemia