Condition category
Respiratory
Date applied
27/02/2007
Date assigned
21/03/2007
Last edited
30/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Semira Manaseki-Holland

ORCID ID

Contact details

Aga Khan Health Services Afghanistan
House No. 648
Street No. 9-B
Sherpoor
Shahr-e-Naw
District 10
Kabul
-
Afghanistan
+93 (0)79 941 0124
semira.manasekiholland@akdn-afg.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

There is no difference in the incidence of pneumonias or their severity for children diagnosed with pneumonia supplemented with 100,000 IU vitamin D at the start of the cold season and 3 months later compared to placebo.

Ethics approval

Institutional Review Board of the Ministry of Public Health of Afghanistan. Approved on 19 November 2006. Ref: 237783

Study design

Double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Pneumonia

Intervention

Vitamin D3 100,000 IU supplementation vs placebo

Intervention type

Supplement

Phase

Not Specified

Drug names

vitamin D

Primary outcome measures

Duration of pneumonia as measured from the date of clinical diagnosis and treatment onset to the last date of illness with any of the following criteria:
1. Respiratory rate according to age and IMCI criteria
2. No danger signs or subcostal recession
3. No fever (temperature < 38.0 °C or < 37.50 °C if < 2 month old)

Secondary outcome measures

1. Incidence of further episodes within 3 months or relapse of pneumonia (The Integrated Management of Childhood Illness [IMCI] defined rapid breathing and cough)
2. Rate of failure to respond to treatment or worsening condition rate (as defined by protocol)

Overall trial start date

09/12/2006

Overall trial end date

30/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Any child, living in the defined areas of Kabul (within the catchment area of the Maywand Teaching Hospital), between 1 week and 18 complete months of age.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

450

Participant exclusion criteria

1. >8 hours after the start of hospital antibiotics treatment
2. Living outside of the study areas of Kabul and child’s families expect to move away within the next 3 months
3. If the child has been diagnosed with clinical rickets or known to have received a course of high dose vitamin D treatment in the past 3 months (doses as high as 300,000 IU are used routinely in India and Pakistan, and thus rarely, some recently returned returnee children may have recently received such doses)
4. If have symptoms of very severe pneumonia (according to IMCI definitions of very severe pneumonia) or other illnesses as the major diagnosis occurring at the same time as pneumonia, such as meningitis, major heart or renal defect, active measles, severe malnutrition requiring separate medical treatment, and suspected tuberculosis
5. Child with severe diarrhoea or vomiting
6. Wheeze at the time of diagnosis (if wheeze develops later the child continues to be in the study)
7. Caretakers do not give consent

Recruitment start date

09/12/2006

Recruitment end date

30/05/2007

Locations

Countries of recruitment

Afghanistan

Trial participating centre

Aga Khan Health Services Afghanistan
Kabul
-
Afghanistan

Sponsor information

Organisation

Aga Khan Health Services Afghanistan (Afghanistan)

Sponsor details

House No. 648
Street No. 9-B
Sherpoor
Shahr-e-Naw
District 10
Kabul
-
Afghanistan
+93 (0)79 941 0124
semira.manasekiholland@akdn-afg.org

Sponsor type

Other

Website

Funders

Funder type

Government

Funder name

New Zealand Aid and International Development Agency (New Zealand)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

In kind donations from Aga Khan Development Network and Maywand Teaching Hospital (funded by the Government of Afghanistan) (Afghanistan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18654949

Publication citations

  1. Results

    Manaseki-Holland S, Zulf Mughal M, Bhutta Z, Qasem Shams M, Vitamin D status of socio-economically deprived children in Kabul, Afghanistan., Int J Vitam Nutr Res, 2008, 78, 1, 16-20, doi: 10.1024/0300-9831.78.1.16.

Additional files

Editorial Notes