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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Drug: Vitamin D supplement

• Registration Number: NCT02215213
• Lead Sponsor: Aga Khan University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-13
• Primary Completion: 2015-07
• Study Completion: 2016-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Vitamin D supplement	Arm 1 is receiving vitamin D supplementation in 2000 IU/day ,
Arm 2 intervention group	Vitamin D supplement	Arm 2 is receiving vitamin D supplementation in 4000/IU per day
Arm 3 control group	Vitamin D supplement	Arm 3 is receiving vitamin D supplementation in 400 IU/day

Primary Outcome Measures

Name	Time	Method
pregnancy out come	At delivery of neonate	Hypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates.

Secondary Outcome Measures

Name	Time	Method
Prevalence of vitamin D deficiency in pregnant women	at recruitment into study (first trimester)	Maternal vitamin D deficiency in the target group.

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan