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

Aga Khan University

Status: Completed

Conditions: Pregnancy

Treatments: Drug: Vitamin D supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02215213

PF8/0911

Details and patient eligibility

About

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

Full 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.

Enrollment: 350 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 3 patient groups

Intervention Group

Active Comparator group

Description:

Arm 1 is receiving vitamin D supplementation in 2000 IU/day ,

Treatment:

Drug: Vitamin D supplement

Drug: Vitamin D supplement

Arm 2 intervention group

Active Comparator group

Description:

Arm 2 is receiving vitamin D supplementation in 4000/IU per day

Treatment:

Drug: Vitamin D supplement

Drug: Vitamin D supplement

Arm 3 control group

Active Comparator group

Description:

Arm 3 is receiving vitamin D supplementation in 400 IU/day

Treatment:

Drug: Vitamin D supplement

Drug: Vitamin D supplement