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Vitamin B12 Supplementation Study

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ClinicalTrials.gov Identifier: NCT00826657
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center

Tracking Information
First Submitted Date  ICMJE January 16, 2009
First Posted Date  ICMJE January 22, 2009
Last Update Posted Date May 21, 2015
Study Start Date  ICMJE October 2004
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations [ Time Frame: 0 and 3 mos ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00826657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
DNA methylation change, and hematological response to B12 supplementation [ Time Frame: 0 and 3 mos ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin B12 Supplementation Study
Official Title  ICMJE Assessment of Functional Vitamin B12 Deficiency in Mexican Women
Brief Summary We hope to learn the clinical and functional signs of sub-clinical vitamin B12 deficiency and its response to supplementation in non-anemic, non-pregnant, and non-lactating women in Rural Mexico. Vitamin B12 is important in hematopoiesis, neuro-cognitive functions and genetic integrity. However vitamin B12 is only found in animal source foods therefore a large segment of the population in developing countries and those practicing vegetarianism are at risk of deficiency of the vitamin. This information will help decide weather supplementation with vitamin B12 is necessary in such populations for public health reasons.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Vitamin B12 Deficiency
Intervention  ICMJE
  • Dietary Supplement: Vitamin B12
    500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study
  • Dietary Supplement: placebo
    placebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study
    Other Name: sugar pill
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Receive placebo (sugar pill) during the intervention. Received a 1000 mg vitamin B12 injection at the end of the study.
    Intervention: Dietary Supplement: placebo
  • Active Comparator: Vitamin B12
    Received 500 micrograms vitamin B12 per day during the study Received a 1000 mg vitamin B12 injection at the start of the study
    Intervention: Dietary Supplement: Vitamin B12
Publications * Shahab-Ferdows S, Anaya-Loyola MA, Vergara-Castañeda H, Rosado JL, Keyes WR, Newman JW, Miller JW, Allen LH. Vitamin B-12 supplementation of rural Mexican women changes biochemical vitamin B-12 status indicators but does not affect hematology or a bone turnover marker. J Nutr. 2012 Oct;142(10):1881-7. Epub 2012 Aug 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2009)
180
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women age 20-59, apparently healthy, no severe B12 deficiency

Exclusion Criteria:

  • pregnancy, lactation, anemia and disease states
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00826657
Other Study ID Numbers  ICMJE 200412519-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party USDA, Western Human Nutrition Research Center
Study Sponsor  ICMJE USDA, Western Human Nutrition Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account USDA, Western Human Nutrition Research Center
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP