NCT03098810

Brief Summary

Zinc supplementation effect on appetite and growth of malnourished children

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_4

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

March 2, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

March 2, 2017

Last Update Submit

March 31, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Appetite

    Child eating behavior questionnaire

    From start of supplementation to the end of the three months of supplementation

Secondary Outcomes (2)

  • Weight

    From start of supplementation to the end of the three months of supplementation

  • Height

    From start of supplementation to the end of the three months of supplementation

Study Arms (2)

Normal children

PLACEBO COMPARATOR

Placebo

Other: Placebo

Malnourished children

EXPERIMENTAL

Oral zinc sulphate syrup

Drug: Zinc sulphate

Interventions

Oral syrup zinc sulphate

Malnourished children
PlaceboOTHER

Oral syrup placebo

Normal children

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • primary malnourished

You may not qualify if:

  • zinc supplementation in the previous 3 months Children with chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • Marian Girgis

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 2, 2017

First Posted

April 4, 2017

Study Start

April 1, 2017

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share