Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Vitamin D Supplementation on the Incidence of Pneumonia in Children in Afghanistan: a Randomized Controlled Trial
Brief Summary: Background: Pneumonia is the leading cause of childhood mortality, accounting for 19% of the 10.6 million deaths that occur each year1. Case-control studies from Ethiopia2 and India3 suggest that sub-clinical vitamin D deficiency may increase ten times the risk of pneumonia in children. We postulate that controlling childhood vitamin D deficiency has the potential to dramatically reduce the incidence of pneumonia and save \>700,000 lives each year since vitamin D deficiency is widespread in developing countries.

Aim: To investigate whether 3-monthly oral supplementation of 100,000iu vitamin D reduces pneumonia and its consequences among children aged 1-12 months (followed for 18 months), living in a deprived area of Kabul, Afghanistan, where \>70% of young children are vitamin D deficient (\<8ng/dl). The effect of vitamin D on the incidence of other diseases, in particular diarrhea and rickets will also be investigated.

Methods: Randomised double-blind placebo-controlled trial: 3000 children will be randomised to receive either 6 doses of vitamin D or placebo. The first dose will be given at the start of autumn and the second and subsequent doses every 3 months thereafter; children will be followed for 18 months. Incidence of pneumonia will be ascertained though weekly home visits (active surveillance) and from attendances and admissions at the trial clinic and wards in the hospital serving the study area (passive surveillance).


Options:
A: Inclusion criteria:

1. 28 0/7-36 6/7 weeks gestational age (GA) at birth;
2. family identifies the child as black or African American;
3. \< 28 days of supplemental oxygen (subsequent oxygen therapy for \< 72 hrs for a brief subsequent illness or surgery will be allowed);
4. admitted to a participating site NICU, special care nursery, transitional care nursery, or well-baby nursery as a neonate; and
5. \< 40 weeks corrected GA at enrollment.

Exclusion criteria:

1. BPD (\> 28 days of supplemental oxygen);
2. pre-existing diagnosis of moderate to severe osteopenia of prematurity and/or alkaline phosphatase \> 700;
3. history of fracture;
4. gastrointestinal surgery, including for NEC;
5. known gastrointestinal malabsorption;
6. major congenital anomaly;
7. congenital pulmonary or airway disorder (e.g., cystic fibrosis, tracheomalacia, swallowing disorder, bronchopulmonary sequestration);
8. documented wheezing or stridor prior to enrollment;
9. previous vit. D supplementation with \> 400 IU/day;
10. family plans to move more than 60 miles from CWRU or other pre-defined radius at other sites;
11. baseline hypo- or hypercalcemia, hypo- or hyperphosphatemia; and
12. baseline 25(OH) D level \< 10 ng/ml.
B: Inclusion Criteria:

* Pregnant women from 20-22 weeks of gestation and their infants, who will agree to take part in this study, will be enrolled.

Exclusion Criteria:

* Pregnant women with pre existing type 1 or type II diabetes
* Women with multiple fetuses, babies (twins, triplets)
* Pregnant women with high level of Vitamin D
* Babies with multiple congenital anomalies
* Babies with serious birth injury, birth asphyxia and serious infections
* Low birth weight less than 1.5
* Refuse to participate in the study
C: Inclusion Criteria:

1. 1 to 11 month old infants living in the study area
2. caretakers are willing to give consent to take part in the study

Exclusion Criteria:

1. the family is likely to migrate out of the study area within the next 18 months
2. the child has been diagnosed with rickets or known to have received a course of vitamin D treatment in the past 3 monDths.
3. Child with Kwashiorkor or Marasmus.
D: Inclusion Criteria:

* Healthy singleton term born infants of appropriate size for gestational age (AGA) according to the Centers for Disease Control growth charts based on weight at birth between the 5th and 95th percentiles for sex; and born to healthy breastfeeding women. This allows us to assess growth and bone mineral accretion without bias of intrauterine growth restriction.

Exclusion Criteria:

* Infants of mothers with history of gestational diabetes or hypertension in pregnancy; chronic alcohol use; malabsorption syndromes due to malabsorption of vitamin D (celiac disease, Crohn's etc.); and multiple births.
* Should any exclusion criteria be identified after recruitment, the infant will be excluded from the main analyzes, but followed in a separate arm as intent-to-treat.

Answer: C