The effect of vitamin D supplementation at diagnosis of pneumonia upon response to treatment

ISRCTN	ISRCTN61245920
DOI	https://doi.org/10.1186/ISRCTN61245920
Protocol serial number	N/A
Sponsor	Aga Khan Health Services Afghanistan (Afghanistan)
Funders	New Zealand Aid and International Development Agency (New Zealand), In kind donations from Aga Khan Development Network and Maywand Teaching Hospital (funded by the Government of Afghanistan) (Afghanistan)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Semira Manaseki-Holland
Scientific

Aga Khan Health Services Afghanistan
House No. 648, Street No. 9-B
Sherpoor, Shahr-e-Naw
District 10
Kabul
-
Afghanistan

Phone	+93 (0)79 941 0124
Email	semira.manasekiholland@akdn-afg.org

Primary study design	Interventional
Study design	Double blind randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Institutional Review Board of the Ministry of Public Health of Afghanistan. Approved on 19 November 2006. Ref: 237783
Health condition(s) or problem(s) studied	Pneumonia
Intervention	Vitamin D3 100,000 IU supplementation vs placebo
Intervention type	Supplement
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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)
Completion date	30/05/2007

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Week
Upper age limit	18 Months
Sex	Not Specified
Target sample size at registration	450
Key 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.
Key exclusion criteria	1. >8 hours after the start of hospital antibiotics treatment 2. Living outside of the study areas of Kabul and childs 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
Date of first enrolment	09/12/2006
Date of final enrolment	30/05/2007

Aga Khan Health Services Afghanistan

Kabul
-
Afghanistan

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2008		Yes	No