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OpenTrials
Completed

NCT Number: NCT00826657

Vitamin B12 Supplementation Study

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.

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Key information

Conditions

Vitamin B12 Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

20 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Autonoma de Queretaro

Querétaro, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnancy, lactation, anemia and disease states

Treatment and study plan

Vitamin B12

Dietary Supplement

500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study

Placebo

Dietary Supplement

placebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study

Other names: sugar pill

Primary outcomes

  1. response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations

    Time frame: 0 and 3 mos

Secondary outcomes

  1. DNA methylation change, and hematological response to B12 supplementation

    Time frame: 0 and 3 mos

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Registry information

Official study title

Assessment of Functional Vitamin B12 Deficiency in Mexican Women

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Jan 22, 2009
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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