AnemiaPhase 1/2NCT02181348
Effect of Vitamin E Supplementation on Hemoglobin Levels in Healthy Adults
A Phase 1/2 study testing Vitamin E in people with Anemia, run by Aga Khan University at 1 site in Pakistan.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 357 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2008to Oct 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Vitamin E in Enhancing Erythropoiesis and the Molecular Mechanism of the Action of Vitamin E on Erythropoietin-secreting Cells
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.
Read the 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.
- Conditions
- Anemia
- Being tested
- Vitamin E, placebo (edible oil)
- Keywords
- Vitamin E, Hemoglobin, mild anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
Also called Evion
dl-alpha tocopheryl acetate 400 mg once daily for 3 months
placebo (edible oil)Drug
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Vitamin E supplementation) | Active comparator | Vitamin E 400 mg once daily for 3 months Receives: Drug: Vitamin E |
| placebo (edible oil) | Placebo comparator | Not described Receives: Drug: placebo (edible oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin levels
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startNov 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tanveer Jilani, Aga Khan University
- Investigators
- Dr. Tanveer Jilani, MBBS, M.Phil, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181348
- Sponsor's protocol ID
- TJilani
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
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.
Jilani T, Azam I, Moiz B, Mehboobali N, Perwaiz Iqbal M. Positive Association of Vitamin E Supplementation with Hemoglobin Levels in Mildly Anemic Healthy Pakistani Adults. Int J Vitam Nutr Res. 2015;85(1-2):39-49. doi: 10.1024/0300-9831/a000222.
PubMed 26780276
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin E in Enhancing Erythropoiesis and the Molecular Mechanism of the Action of Vitamin E on Erythropoietin-secreting Cells
- ClinicalTrials.gov ID
- NCT02181348
- Acronym / sponsor ID
- TJilani
- Conditions
- Anemia
- Keywords
- Vitamin E, Hemoglobin, mild anemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Vitamin E supplementation) | Active comparator | Drug: Vitamin EVitamin E 400 mg once daily for 3 months |
| placebo (edible oil) | Placebo comparator | Drug: placebo (edible oil) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin EAlso: Eviondl-alpha tocopheryl acetate 400 mg once daily for 3 months | Drug | Intervention (Vitamin E supplementation) |
| placebo (edible oil) | Drug | placebo (edible oil) |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
- Background1. 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.
- Derived from this study: PubMed 26780276Jilani T, Azam I, Moiz B, Mehboobali N, Perwaiz Iqbal M. Positive Association of Vitamin E Supplementation with Hemoglobin Levels in Mildly Anemic Healthy Pakistani Adults. Int J Vitam Nutr Res. 2015;85(1-2):39-49. doi: 10.1024/0300-9831/a000222.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Tanveer Jilani, MBBS, M.Phil principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin E in people with Anemia, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02181348, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2014.