Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan.

Study Overview
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Brief Summary
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Vitamin D deficiency is wide spread in South Asian population and is contributing to burden of disease in this region including Pakistan. The relative importance of vitamin D deficiency, mutation in its receptor and maternal and child health has not been established in Pakistan and population based studies are required to explore and avert the maternal and Neonatal complications and consequences of Vitamin D deficiency The trial will evaluate the effectiveness of Vitamin D supplementation to pregnant women and their Infants. It will be a double blind placebo controlled trial, which will be conducted in a rural district of Pakistan.

Detailed Description
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The investigators are proposing a community based introduction of vitamin D supplementation and we intend to understand the complex relationship between vitamin D, the growth factors and maternal and infant anthropometric variables and hope to unravel the reasons of vitamin D deficiency in our population. The investigators expect that if vitamin D is supplemented to pregnant women and their newborn infants it will inevitably replenish the micronutrient stores and aid to resolve the maternal and neonatal morbidity due to Vitamin D deficiency.

Official Title
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Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan

Conditions
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Vitamin D Deficiency, Pre Eclampsia, Stillbirths, Low Birth Weight, Prematurity

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maternal and Neonatal Intervention Arm<br>Pregnant women will be individually randomized; a daily dose of vitamin D in 4000 IU will be given to Intervention group, started at 20-22 weeks of pregnancy till the time of delivery. The infants of this group will further stratify into two groups, one group will receive 400 IU of Vitamin D for 6 months as Intervention. | Dietary Supplement: Vitamin D<br>* Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks<br>|
| Placebo Comparator: Maternal and Neonatal Control Arm<br> | Dietary Supplement: Placebo<br>* Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and Neonatal complications | Preeclampsia, hypertension ,poor weight gain etc during pregnancy.Still birth rates, Rate of low birth weight, prematurity,Neonatal seizures, Infants with growth failure, signs and symptoms of vitamin D deficiency. Infants with infections: pneumonia, diarrhea and Receptor polymorphism | six months post enrolement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency |  | Six months post recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Effectiveness, Pregnant women and their neonates