NCT00394862

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

5 months

First QC Date

October 31, 2006

Last Update Submit

March 29, 2012

Conditions

Neural Tube Defects

Outcome Measures

Primary Outcomes (2)

  • serum folate level

  • red blood cell folate

Secondary Outcomes (6)

  • homocysteine

  • ferritin

  • serum zinc

  • serum B12

  • blood pressure

  • +1 more secondary outcomes

Interventions

multivitaminDRUG

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • female
  • aged 15-49

You may not qualify if:

  • pregnant
  • lactating less than 3 months
  • severely anemic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neural Tube Defects

Interventions

Geritol

Condition Hierarchy (Ancestors)

Nervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Reynaldo Martorell, PHD, MPH

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 1, 2006

Study Start

January 1, 2006

Primary Completion

June 1, 2006

Study Completion

July 1, 2006

Last Updated

April 2, 2012

Record last verified: 2012-03