Vitamin B12 Supplementation Study
Assessment of Functional Vitamin B12 Deficiency in Mexican Women
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 16, 2009
CompletedFirst Posted
Study publicly available on registry
January 22, 2009
CompletedMay 21, 2015
May 1, 2015
10 months
January 16, 2009
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations
0 and 3 mos
Secondary Outcomes (1)
DNA methylation change, and hematological response to B12 supplementation
0 and 3 mos
Study Arms (2)
placebo
PLACEBO COMPARATORReceive placebo (sugar pill) during the intervention. Received a 1000 mg vitamin B12 injection at the end of the study.
Vitamin B12
ACTIVE COMPARATORReceived 500 micrograms vitamin B12 per day during the study Received a 1000 mg vitamin B12 injection at the start of the study
Interventions
500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study
placebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study
Eligibility Criteria
You may qualify if:
- Women age 20-59, apparently healthy, no severe B12 deficiency
You may not qualify if:
- pregnancy, lactation, anemia and disease states
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Autonoma de Queretaro
Querétaro, Mexico
Related Publications (1)
Shahab-Ferdows S, Anaya-Loyola MA, Vergara-Castaneda 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. doi: 10.3945/jn.112.165712. Epub 2012 Aug 22.
PMID: 22915298DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2009
First Posted
January 22, 2009
Study Start
October 1, 2004
Primary Completion
August 1, 2005
Study Completion
November 1, 2006
Last Updated
May 21, 2015
Record last verified: 2015-05