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Effect of Vitamin E Supplementation on Hemoglobin Levels in Healthy Adults

2014년 7월 2일 업데이트: Dr. Tanveer Jilani, Aga Khan University

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

357

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Sindh
      • Karachi, Sindh, 파키스탄, 74800
        • Aga Khan University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Intervention (Vitamin E supplementation)
Vitamin E 400 mg once daily for 3 months
dl-alpha tocopheryl acetate 400 mg once daily for 3 months
다른 이름들:
  • 에비온
위약 비교기: placebo (edible oil)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in hemoglobin levels
기간: 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).
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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Dr. Tanveer Jilani, MBBS, M.Phil, Aga Khan University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2008년 11월 1일

기본 완료 (실제)

2011년 10월 1일

연구 완료 (실제)

2011년 10월 1일

연구 등록 날짜

최초 제출

2014년 7월 2일

QC 기준을 충족하는 최초 제출

2014년 7월 2일

처음 게시됨 (추정)

2014년 7월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 7월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 7월 2일

마지막으로 확인됨

2014년 7월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Vitamin E에 대한 임상 시험

구독하다