Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy- a Dose Comparison Trial

Study Overview
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Brief Summary
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The study is randomized blinded trial of Vitamin D supplementation to pregnant women; the study participants will receive Vitamin D in supplement form. Pregnant women will be individually randomized to three groups receiving a dose of 400, 2000 and 4000 IU/ day till the time of delivery.A blood sample will also be collected from the participant at the time of recruitment /before the starting of the supplementation for the assessment of Calcium, Phosphorus, Alkaline Phosphatase and Vitamin D levels. The second blood sample for vitamin D level to assess vitamin D status will be done after completion of the supplementation phase at the time of delivery (till 48 hours of delivery). The samples will be sent to Aga Khan University laboratory

Detailed Description
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The investigators hypothesize that Pakistani mothers as darkly pigmented, will require substantially higher oral supplementation with vitamin D to replenish the micronutrient stores and aid to resolve associated maternal and neonatal morbidity due to Vitamin D deficiency. The investigators expect that if vitamin D is supplemented to pregnant women, their newborn infants would inevitably replenish the micronutrient stores and aid to resolve the maternal and neonatal morbidity due to Vitamin D deficiency.This is hospital based double blinded trial, study participants divided into three groups which will receive Vitamin D supplementation in 400, 2000 and 4000 International Units. The group which will receive 400 IUs will be treated as control group.

Official Title
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Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Vitamin D supplement
* Drug: Vitamin D supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women aged 15 - 45 years Less than 16 weeks pregnant from Last menstrual period. Agree to take part in this study, will be enrolled. Exclusion Criteria: Pregnant women with pre existing type 1 or type II diabetes, Pregnant women with pre existing hypertension Women with multiple fetuses, babies (twins, triplets) Women with fetal anomaly in scan Refuse to participate in the study

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>Arm 1 is receiving vitamin D supplementation in 2000 IU/day , | Drug: Vitamin D supplement<br>* comparison of different dosages of vitamin D<br>* Other names: LOT ID AKUH COMPOUNDING 2305012014;Drug: Vitamin D supplement<br>* comparison of different dosages of vitamin D Supplement<br>* Other names: Brand name: Vitamin D3;|
| Active Comparator: Arm 2 intervention group<br>Arm 2 is receiving vitamin D supplementation in 4000/IU per day | Drug: Vitamin D supplement<br>* comparison of different dosages of vitamin D<br>* Other names: LOT ID AKUH COMPOUNDING 2305012014;Drug: Vitamin D supplement<br>* comparison of different dosages of vitamin D Supplement<br>* Other names: Brand name: Vitamin D3;|
| Active Comparator: Arm 3 control group<br>Arm 3 is receiving vitamin D supplementation in 400 IU/day | Drug: Vitamin D supplement<br>* comparison of different dosages of vitamin D<br>* Other names: LOT ID AKUH COMPOUNDING 2305012014;Drug: Vitamin D supplement<br>* comparison of different dosages of vitamin D Supplement<br>* Other names: Brand name: Vitamin D3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy out come | Hypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates. | At delivery of neonate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of vitamin D deficiency in pregnant women | Maternal vitamin D deficiency in the target group. | at recruitment into study (first trimester) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, pregnancy, Pakistan