Effect of Vitamin E Supplementation on Hemoglobin Levels in Healthy Adults

NCT02181348 | Completed Phase 1

• 1 other identifier: TJilani
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

Vitamin E, Hemoglobin, mild anemia

Outcome Measures

Primary Outcomes (1)

• 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).

  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).

Study Arms (2)

Intervention (Vitamin E supplementation)

ACTIVE COMPARATOR

Vitamin E 400 mg once daily for 3 months

Drug: Vitamin E

placebo (edible oil)

PLACEBO COMPARATOR

Drug: placebo (edible oil)

Interventions

Vitamin E DRUG

dl-alpha tocopheryl acetate 400 mg once daily for 3 months

Also known as: Evion

Intervention (Vitamin E supplementation)

placebo (edible oil) DRUG

placebo (edible oil)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 26780276 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Vitamin E; Tocopherols; Oils

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Lipids

Study Officials

• Dr. Tanveer Jilani, MBBS, M.Phil

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Instructor

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 3, 2014
• Study Start: November 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 3, 2014

Record last verified: 2014-07

Locations

PA (1)