Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy- a Dose Comparison Trial
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ClinicalTrials.gov Identifier: NCT02215213 |
Recruitment Status :
Completed
First Posted : August 13, 2014
Last Update Posted : July 18, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy | Drug: Vitamin D supplement | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 350 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | January 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Intervention Group
Arm 1 is receiving vitamin D supplementation in 2000 IU/day ,
|
Drug: Vitamin D supplement
comparison of different dosages of vitamin D
Other Names:
Drug: Vitamin D supplement comparison of different dosages of vitamin D Supplement
Other Name: Brand name: Vitamin D3 |
Active Comparator: Arm 2 intervention group
Arm 2 is receiving vitamin D supplementation in 4000/IU per day
|
Drug: Vitamin D supplement
comparison of different dosages of vitamin D
Other Names:
Drug: Vitamin D supplement comparison of different dosages of vitamin D Supplement
Other Name: Brand name: Vitamin D3 |
Active Comparator: Arm 3 control group
Arm 3 is receiving vitamin D supplementation in 400 IU/day
|
Drug: Vitamin D supplement
comparison of different dosages of vitamin D
Other Names:
Drug: Vitamin D supplement comparison of different dosages of vitamin D Supplement
Other Name: Brand name: Vitamin D3 |
- pregnancy out come [ Time Frame: At delivery of neonate ]Hypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates.
- Prevalence of vitamin D deficiency in pregnant women [ Time Frame: at recruitment into study (first trimester) ]Maternal vitamin D deficiency in the target group.

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Ages Eligible for Study: | 15 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215213
Pakistan | |
Aga Khan University | |
Karachi, Sindh, Pakistan, 75300 |
Principal Investigator: | Sidrah Nausheen, FCPS | Aga Khan University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr Sidrah Nausheen, Principal Investigator, Aga Khan University |
ClinicalTrials.gov Identifier: | NCT02215213 |
Other Study ID Numbers: |
PF8/0911 |
First Posted: | August 13, 2014 Key Record Dates |
Last Update Posted: | July 18, 2016 |
Last Verified: | July 2016 |
Vitamin D pregnancy Pakistan |
Vitamin D Ergocalciferols Cholecalciferol Vitamins |
Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |