NCT03040219

Brief Summary

Folic acid as a appetizer in primary malnutrition

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 20, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

January 20, 2017

Last Update Submit

March 11, 2017

Conditions

Primary Malnurtrition

Outcome Measures

Primary Outcomes (1)

  • Appetite

    Child eating behaviour questionnaire

    Through study completion_ after 3 months from start of supplementation

Secondary Outcomes (1)

  • Leptin and ghrelin hormone

    3 months

Other Outcomes (1)

  • Growth

    Through study completion -after 3 months from start of supplementation

Study Arms (2)

Treatment group

ACTIVE COMPARATOR
Drug: Folic Acid

Control

PLACEBO COMPARATOR
Drug: Folic Acid

Interventions

Folic AcidDRUG

Tablets

ControlTreatment group

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Primary malnourished children

You may not qualify if:

  • previous folic supplementation in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marian girgis

Cairo, Egypt

Location

MeSH Terms

Interventions

Folic Acid

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Marian Girgis

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marian Girgis

CONTACT

0201223646224Mariangirgis2009@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 20, 2017

First Posted

February 2, 2017

Study Start

April 1, 2017

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

EG(1)