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Completed

NCT Number: NCT00394862

Efficacy of Weekly Versus Daily Folic Acid Supplementation

Investigate the efficacy of weekly versus daily of folic acid supplementation on improving folate, vitamin B12,

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Key information

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

460 women of a rural community in the western highlands of Guatemala were recruited for participation in the double-blinded study led by Emory University and the Institute of Nutrition of Central America and Panama (INCAP). The women were randomly assigned one of 4 vitamin treatments containing different levels of folic acid, Vitamin B12, iron and zinc. The treatments were as follows:

  • weekly dose of folic acid at 5000ug, iron at 120 mg, zinc at 30mg, and B12 at 16.8 ug;
  • weekly dose of folic acid at 2800ug, iron at 120mg, zinc at 0mg and B12 at 16.8ug;
  • daily dose of folic acid at 400ug, iron at 60mg, zinc at 15mg, B12 at 2.4ug; and
  • daily dose of folic acid at 200ug, iron at 50mg, zinc at 0mg, and B12 at 2.4ug.

The women, aged 15-49, received the vitamins daily for 3 months. Anthropometric data and blood samples were taken at baseline and post-supplementation. The participants also completed a series of dietary interviews at baseline and post-intervention. No pregnant or lactating mothers were admitted into the study, nor severely anemic females. Blood samples were sent to the National Laboratory in Cuernavaca, Mexico, for analysis of serum folate levels.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • female
  • aged 15-49

Exclusion criteria

  • pregnant
  • lactating less than 3 months
  • severely anemic

Treatment and study plan

multivitamin

Drug

Primary outcomes

  1. serum folate level

  2. red blood cell folate

Secondary outcomes

  1. homocysteine

  2. ferritin

  3. serum zinc

  4. serum B12

  5. blood pressure

  6. depression

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Nov 1, 2006
Registry last updated
Apr 2, 2012

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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